Sarcopenia in ElderlyHIP-REGENNCT07429955
Impact of Pre-operative Sarcopenia on Functional Recovery After Hip Arthroplasty in Older Adults
A study testing Total hip replacement, Blood sampling and Muscle biopsies in people with Sarcopenia in Elderly and Osteoarthritis (OA), run by University Hospital, Montpellier at 1 site in France.
Trial summary
This single-centre, exploratory study at Montpellier University Hospital will investigate whether having low muscle mass and strength before hip-replacement surgery, a condition called sarcopenia, impact the return to everyday independence in people aged 75 years or older. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Osteoarthritis (OA), Hip Fracture Surgeries
- What is being tested?
- Total hip replacement, Blood sampling and Muscle biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2026to 17 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly subjects undergoing surgical hip replacement for fracture of the upper end of the femur or severe hip osteoarthritis.
Who cannot join
- Contraindications to MRI : pacemaker, metallic implants.
- Presence of a lower-limb prosthesis on the contralateral side to the surgery that may interfere with quadriceps mass measurements.
- Progressive high-grade neoplasia.
- Documented major cognitive disorders
- Under legal protection measures (guardianship, conservatorship, or curatorship).
- Subjects not affiliated with or not covered by a social security system.
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- Participation in another ongoing study with an active exclusion period.
- Fracture with a suspicion of underlying neoplasia.
- Placement of a lower-limb prosthesis on the surgical side within the last 12 months.
- Inability to walk with or without human/technical assistance prior to fracture.
- Active inflammatory joint disease (rheumatoid arthritis, spondyloarthritis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Montpellier, 34090
Jean Baptiste Robiaud, Assistant head physician, +33629184092, jbrobiaud@gmail.com
Jean Baptiste ROBIAUD, Assistant head physician
About this study
This single-centre, exploratory study at Montpellier University Hospital will investigate whether having low muscle mass and strength before hip-replacement surgery, a condition called sarcopenia, impact the return to everyday independence in people aged 75 years or older. About 20 volunteers, scheduled for surgery because of a recent femoral-neck fracture or severe arthritis that no longer responds to usual care, will give consent, answer brief health questionnaires, attempt simple walking and chair-rise tests if possible, and provide a small blood sample. While they are already under anaesthesia for their planned operation, the surgical team will take a tiny muscle sample through the same incision, so no extra cuts are needed. During the hospital stay or shortly after discharge, each participant will have a painless MRI scan of the thigh muscles and a very-low-dose bone scan (DXA) to measure muscle and bone health. The research team will then telephone participants at 3 and 6 months to ask about daily activities, walking ability, and any complications. The study lasts about six months for each person and does not alter their usual medical or rehabilitation care. Potential benefits include close follow-up, personalised feedback on muscle and bone results, and helping doctors learn whether pre-surgery muscle weakness predicts slower recovery-information that could guide future, more personalised exercise and nutrition programs. Extra study procedures carry only minimal risks: a routine blood draw, scans with none (MRI) or very little (DXA) radiation, and a muscle biopsy taken during surgery. Taking part is entirely voluntary, and participants may withdraw at any time without affecting their current or future care. The whole project will run for 18 months.
Read the detailed description
Hip-REGEN is an exploratory, single-centre, prospective, longitudinal pathophysiology study conducted at Montpellier University Hospital to clarify whether the degree of pre-operative sarcopenia modulates functional recovery after hip arthroplasty in patients ≥ 75 years who undergo the procedure either for a recent femoral-neck fracture or severe hip osteoarthritis.
The increasing worldwide burden of musculoskeletal diseases, represents major costs for the healthcare system. Osteoarthritis, which affects around 595 million people worldwide, and osteoporosis, defined by the WHO as a reduction in bone mineral density, are two of the main age-related musculoskeletal pathologies. In France, between 2008 and 2014, around 650,000 hip prostheses surgeries were necessary to treat severe coxofemoral osteoarthritis, and around 65,000 hip prostheses surgeries are necessary every year to treat fractures of the upper end of the femur, occuring mainly due to osteoporosis, associated with significant loss of autonomy and high one-year mortality rate (20%).
We hypothesise that lower muscle mass and strength before surgery will negatively impact the 3- and 6-month functional recovery, assessed by the Barthel Index. This association could be mediated by impaired muscle regenerative capacity and endocrine function, including myokines and related systemic circulating biomarkers. Twenty participants (10 hip fractures, 10 hip osteoarthritis) will be consecutively enrolled over 12 months, in the orthopaedic service, a sample size chosen to demonstrate feasibility and to cover the cost of ex-vivo assays while maintaining balanced sex representation. After written informed consent, baseline (Visit 1) assessments include Barthel Index, Katz ADL, Lawton IADL, physical activity (IPAQ-SF), SARC-F, comorbidity (Charlson), nutritional and cognitive screens, hand-grip dynamometry, and blood sampling for biobanking. Pre-operative sarcopenia status is classified according to EWGSOP2 thresholds for grip strength and appendicular lean mass by DXA (Visit 3), complemented by quantitative MRI (Visit 3) of the quadriceps to detect fatty infiltration that DXA may miss. All imageries will be performed either few days before or after the hip replacement for limited biais.
During the arthroplasty (Visit 2) a micro-biopsy of the gluteus medius is obtained through the surgical approach without additional incision, and bone-cartilage and synovium, normally discarded are collected and immediately transferred on ice to INSERM U1046 or U1183 for conditionning for cell culture, mechanistic assays and long-term storage (with participant opt-in for the biological collection). Within 15 days post-operatively (Visit 3) each participant undergoes a high-resolution quadriceps MRI and low-dose DXA to finalise muscle characterisation and obtain bone density. Telephone follow-ups at 3 months (Visit 4) and 6 months (Visit 5) repeat the Barthel Index and capture complications, readmissions and living arrangements; additional geriatric assessment is offered if recovery is unsatisfactory as part of routine care.
The primary endpoint is the variation in Barthel Index between baseline, 3 months, and 6 months. Key secondary analyses relate pre-operative sarcopenia metrics to: (i) in-vitro myoblast regeneration and endocrine function of skeletal muscle; (ii) circulating concentrations of muscle biomarkers (e.g. myostatin, follistatin, irisin, IL-6, IGF-1, lactate) ; and (iii) MRI-derived quadriceps composition. Laboratory procedures follow standardised culture and imaging protocols and include quality-controlled quantification of muscle satellite-cell (MuSC) proliferation, differentiation and senescence markers, as well as endocrine function including extracellular vesicle composition analysis, histological scoring of cartilage explants, and chondrocyte phenotypes and mesenchymal stem cells multipotency.
All data are entered into an electronic case-report form with automated range and consistency checks; monitoring is performed by the CHU Montpellier sponsor through on-site visits, central statistical surveillance and adherence to French Jardé Category-1 regulations (biopsy constitutes the main additional intervention). The statistical analysis plan, finalised before database lock, prespecifies descriptive statistics, non-parametric tests (Wilcoxon-Mann-Whitney, Fisher) for the primary endpoint, and exploratory Spearman correlations between sarcopenia measures, regenerative indices and functional change; given the pilot nature, 95 % confidence intervals will be reported without formal p-values.
Adverse events related to additional procedures are expected to be minimal (venepuncture, MRI without ionising radiation, DXA ≈0.001 mSv, and intra-operative muscle biopsy performed under the same anaesthesia). All events will be captured and reported according to Good Clinical Practice; a data-safety officer affiliated with the institutional vigilance unit will review safety quarterly. The study duration per participant is six months; the overall project, including analysis and dissemination, spans 18 months. Results, positive, negative or inconclusive, will be submitted to peer-reviewed journals and uploaded to ClinicalTrials.gov within one year of completion, in line with French and EU transparency requirements. By integrating in-vivo phenotyping, advanced imaging and ex-vivo regenerative testing across two complementary hip-surgery models, Hip-REGEN should generate mechanistic hypotheses and candidate biomarkers to guide future stratified rehabilitation or pre-habilitation trials in sarcopenic older adults.
- Being tested
- Total hip replacement, Blood sampling, Muscle biopsies, Collection of joint samples derived from surgical waste, DXA
- Keywords
- Sarcopenia in Elderly, Osteoarthritis (OA), Hip Fracture Surgeries, Functional Recovery, Rehabilitation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacementProcedure or surgery
Hip replacement is a surgical procedure performed as part of routine care for patients with a fracture of the upper end of the femur or severe osteoarthritis of the hip.
Blood samplingBiological
Four heparinized tubes of 5 ml of blood will be collected from each patient at inclusion. All blood samples will be stored in a biobank for subsequent analyses targeting biomarkers potentially associated with sarcopenia and muscle regeneration.
Muscle biopsiesBiological
Performed during hip arthroplasty
Collection of joint samples derived from surgical wasteBiological
Performed during hip arthroplasty
DXARadiation
Within 15 days following the surgical procedure, during hospitalization/rehabilitation
MRIOther
Within 15 days following the surgical procedure, during hospitalization/rehabilitation
Handgrip strength testOther
Measurement of handgrip strength using a hand dynamometer
| Study group | Role | What they receive |
|---|---|---|
| Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery | Experimental | Not described Receives: Procedure: Total hip replacement; Biological: Blood sampling; Biological: Muscle biopsies; Biological: Collection of joint samples derived from surgical waste; Radiation: DXA; Other: MRI; Other: Handgrip strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Barthel Index at 3 months post-operative
A 10-point shift is the minimal clinically important difference; after hip-fracture surgery a mean 25-point decline at 3 months is anticipated.
Measured: Baseline and 3 months
Change from Baseline in the Barthel Index at 6 months post-operative
Measured: Baseline and 6 months
Measurement of hand-grip strength via dynamometry
Assessment of preoperative sarcopenia severity
Measured: Baseline
Measurement of appendicular lean mass by DXA
Assessment of preoperative sarcopenia severity
Measured: Prior to surgery or within 7 days postoperatively
Measurement of quadriceps mass by MRI
Assessment of preoperative sarcopenia severity.
Because DXA cannot differentiate intramuscular fat or connective tissue, 3-D Dixon/IDEAL MRI of the quadriceps-the muscle most affected by ageing-will segment contractile tissue and compute muscle mass (volume × 1.04 kg · L-¹).
Measured: Prior to surgery or within 7 days postoperatively
Secondary outcomes (16)
Number of myoblastic progenitors at proliferation onset
Quantification, and correlation with Barthel-index at 3 month, of the number of myoblastic progenitor cells obtained after in-vitro proliferation for 3 days of primary human satellite cells isolated from ~25 mg gluteus micro-biopsies collected during surgery under general anaesthesia. The number of myoblasts will be determined by immunofluorescence staining and quantified using automated image analysis from at least five random microscopic fields per culture well (expressed as cells/mm² at day 3 of proliferation).
Measured: Intraoperative
Mean myotube surface area at differentiation end
Quantification, and correlation with Barthel-index at 3 month, of the mean surface area of myotubes at the end of the differentiation phase from primary human satellite cells isolated from ~25 mg gluteus-medius micro-biopsies collected during surgery under general anaesthesia. Myotube surface area will be determined by immunofluorescence staining and quantified using automated image analysis from at least five random microscopic fields per culture well, expressed in square micrometres (µm²).
Measured: Intraoperative
Proportion of senescent MSCs
Quantification, and correlation with Barthel-index at 3 month, of the proportion of senescent MSCs among primary MSC cultures isolated from bone fragments obtained during hip arthroplasty (surgical waste) by bone marrow flush. Senescence will be assessed using β-galactosidase staining, and the proportion of senescent cells will be calculated as the percentage of β-gal⁺ cells among total DAPI⁺ nuclei, averaged from at least five random microscopic fields per culture well (expressed as % of β-gal⁺ MSCs).
Measured: Intraoperative
Number of chondrocytes obtained from MSCs at differentiation end
Quantification, and correlation with Barthel-index at 3 month, of the number of chondrocytes obtained at the end of the differentiation phase from primary human mesenchymal stromal cells (MSCs) cultured in chondrogenic differentiation medium. Differentiated cells will be identified by immunofluorescence staining or histological coloration and quantified using automated image analysis from at least five random microscopic fields per culture well, expressed as number of cells per mm².
Measured: Intraoperative
Number of adipocytes obtained from MSCs at differentiation end
Quantification, and correlation with Barthel-index at 3 month, of the number of adipocytes obtained at the end of the differentiation phase from primary human mesenchymal stromal cells (MSCs) cultured in adipogenic differentiation medium. Differentiated cells will be identified by immunofluorescence staining or histological coloration and quantified using automated image analysis from at least five random microscopic fields per culture well, expressed as number of cells per mm².
Measured: Intraoperative
Number of osteocytes obtained from MSCs at differentiation end.
Quantification, and correlation with Barthel-index at 3 month, of the number of osteocytes obtained at the end of the differentiation phase from primary human mesenchymal stromal cells (MSCs) cultured in osteogenic differentiation medium. Differentiated cells will be identified by immunofluorescence staining or histological coloration and quantified using automated image analysis from at least five random microscopic fields per culture well, expressed as number of cells per mm².
Measured: Intraoperative
Serum concentation of myostatin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 3 month.
Measured: Baseline and 3 month
Serum concentation of myostatin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 6 month.
Measured: Baseline and 6 month
Serum concentation of follistatin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 3 month.
Measured: Baseline and 3 month
Serum concentation of follistatin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 6 month.
Measured: Baseline and 6 month
Serum concentation of irisin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 3 month.
Measured: Baseline and 3 month
Serum concentation of irisin
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 6 month.
Measured: Baseline and 6 month
Serum concentation of IL-6
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 3 month.
Measured: Baseline and 3 month
Serum concentation of IL-6
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 6 month.
Measured: Baseline and 6 month
Serum concentation of IGF-1
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 3 month.
Measured: Baseline and 3 month
Serum concentation of IGF-1
Preoperative circulating biomarkers predictive of post-arthrosplasty recovery will be identified and validated by quantifying candidate myokines in baseline serum via ELISA and multiplex assays and correlating with Barthel-index at 6 month.
Measured: Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Aug 2026
- Primary completion17 Feb 2028 (estimated)
- Study completion17 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429955
- Sponsor's protocol ID
- RECHMPL23_0348
- Other IDs
- 2024-A02779-38
- Acronym
- HIP-REGEN
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
PubMed 37675071Stein H, Perren SM, Cordey J, Kenwright J, Mosheiff R, Francis MJ. The muscle bed--a crucial factor for fracture healing: a physiological concept. Orthopedics. 2002 Dec;25(12):1379-83. doi: 10.3928/0147-7447-20021201-16. No abstract available.
PubMed 12502201Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49.
PubMed 22473333Brzeszczynska J, Meyer A, McGregor R, Schilb A, Degen S, Tadini V, Johns N, Langen R, Schols A, Glass DJ, Roubenoff R, Ross JA, Fearon KCH, Greig CA, Jacobi C. Alterations in the in vitro and in vivo regulation of muscle regeneration in healthy ageing and the influence of sarcopenia. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):93-105. doi: 10.1002/jcsm.12252. Epub 2017 Dec 6.
PubMed 29214748Fox KM, Magaziner J, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R. Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000;11(1):31-5. doi: 10.1007/s001980050003.
PubMed 10663356Di Monaco M, Vallero F, Di Monaco R, Tappero R, Cavanna A. Muscle mass and functional recovery in men with hip fracture. Am J Phys Med Rehabil. 2007 Oct;86(10):818-25. doi: 10.1097/PHM.0b013e318151fec7.
PubMed 17885314Maden-Wilkinson TM, Degens H, Jones DA, McPhee JS. Comparison of MRI and DXA to measure muscle size and age-related atrophy in thigh muscles. J Musculoskelet Neuronal Interact. 2013 Sep;13(3):320-8.
PubMed 23989253Fuchs CJ, Kuipers R, Rombouts JA, Brouwers K, Schrauwen-Hinderling VB, Wildberger JE, Verdijk LB, van Loon LJC. Thigh muscles are more susceptible to age-related muscle loss when compared to lower leg and pelvic muscles. Exp Gerontol. 2023 May;175:112159. doi: 10.1016/j.exger.2023.112159. Epub 2023 Mar 31.
PubMed 36967049Vergara I, Vrotsou K, Orive M, Gonzalez N, Garcia S, Quintana JM. Factors related to functional prognosis in elderly patients after accidental hip fractures: a prospective cohort study. BMC Geriatr. 2014 Nov 26;14:124. doi: 10.1186/1471-2318-14-124.
PubMed 25425462Gielen E, Dupont J, Dejaeger M, Laurent MR. Sarcopenia, osteoporosis and frailty. Metabolism. 2023 Aug;145:155638. doi: 10.1016/j.metabol.2023.155638. Epub 2023 Jun 20.
PubMed 37348597Di Monaco M, Vallero F, Di Monaco R, Tappero R. Prevalence of sarcopenia and its association with osteoporosis in 313 older women following a hip fracture. Arch Gerontol Geriatr. 2011 Jan-Feb;52(1):71-4. doi: 10.1016/j.archger.2010.02.002. Epub 2010 Mar 5.
PubMed 20207030Haute Autorité de Santé. Prothèses de hanche. Saint-Denis La Plaine: HAS; 2013.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Clynes MA, Gregson CL, Bruyere O, Cooper C, Dennison EM. Osteosarcopenia: where osteoporosis and sarcopenia collide. Rheumatology (Oxford). 2021 Feb 1;60(2):529-537. doi: 10.1093/rheumatology/keaa755.
PubMed 33276373Candel-Parra E, Corcoles-Jimenez MP, Del Egido-Fernandez MA, Villada-Munera A, Jimenez-Sanchez MD, Moreno-Moreno M, Carrion-Gonzalez M, Denia-Cortes A. [Independence in activities of daily living 6 months after surgery in previously independent elderly patients with hip fracture caused by a fall]. Enferm Clin. 2008 Nov-Dec;18(6):309-16. doi: 10.1016/s1130-8621(08)75853-4. Spanish.
PubMed 19080883
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-operative Sarcopenia on Functional Recovery After Hip Arthroplasty in Older Adults
- ClinicalTrials.gov ID
- NCT07429955
- Acronym / sponsor ID
- HIP-REGEN / RECHMPL23_0348
- Keywords
- Sarcopenia in Elderly, Osteoarthritis (OA), Hip Fracture Surgeries, Functional Recovery, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 17 Feb 2028 (estimated)
- Study completion
- 17 Aug 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-centre, exploratory study at Montpellier University Hospital will investigate whether having low muscle mass and strength before hip-replacement surgery, a condition called sarcopenia, impact the return to everyday independence in people aged 75 years or older. About 20 volunteers, scheduled for surgery because of a recent femoral-neck fracture or severe arthritis that no longer responds to usual care, will give consent, answer brief health questionnaires, attempt simple walking and chair-rise tests if possible, and provide a small blood sample. While they are already under anaesthesia for their planned operation, the surgical team will take a tiny muscle sample through the same incision, so no extra cuts are needed. During the hospital stay or shortly after discharge, each participant will have a painless MRI scan of the thigh muscles and a very-low-dose bone scan (DXA) to measure muscle and bone health. The research team will then telephone participants at 3 and 6 months to ask about daily activities, walking ability, and any complications. The study lasts about six months for each person and does not alter their usual medical or rehabilitation care. Potential benefits include close follow-up, personalised feedback on muscle and bone results, and helping doctors learn whether pre-surgery muscle weakness predicts slower recovery-information that could guide future, more personalised exercise and nutrition programs. Extra study procedures carry only minimal risks: a routine blood draw, scans with none (MRI) or very little (DXA) radiation, and a muscle biopsy taken during surgery. Taking part is entirely voluntary, and participants may withdraw at any time without affecting their current or future care. The whole project will run for 18 months.
Detailed description
Hip-REGEN is an exploratory, single-centre, prospective, longitudinal pathophysiology study conducted at Montpellier University Hospital to clarify whether the degree of pre-operative sarcopenia modulates functional recovery after hip arthroplasty in patients ≥ 75 years who undergo the procedure either for a recent femoral-neck fracture or severe hip osteoarthritis.
The increasing worldwide burden of musculoskeletal diseases, represents major costs for the healthcare system. Osteoarthritis, which affects around 595 million people worldwide, and osteoporosis, defined by the WHO as a reduction in bone mineral density, are two of the main age-related musculoskeletal pathologies. In France, between 2008 and 2014, around 650,000 hip prostheses surgeries were necessary to treat severe coxofemoral osteoarthritis, and around 65,000 hip prostheses surgeries are necessary every year to treat fractures of the upper end of the femur, occuring mainly due to osteoporosis, associated with significant loss of autonomy and high one-year mortality rate (20%).
We hypothesise that lower muscle mass and strength before surgery will negatively impact the 3- and 6-month functional recovery, assessed by the Barthel Index. This association could be mediated by impaired muscle regenerative capacity and endocrine function, including myokines and related systemic circulating biomarkers. Twenty participants (10 hip fractures, 10 hip osteoarthritis) will be consecutively enrolled over 12 months, in the orthopaedic service, a sample size chosen to demonstrate feasibility and to cover the cost of ex-vivo assays while maintaining balanced sex representation. After written informed consent, baseline (Visit 1) assessments include Barthel Index, Katz ADL, Lawton IADL, physical activity (IPAQ-SF), SARC-F, comorbidity (Charlson), nutritional and cognitive screens, hand-grip dynamometry, and blood sampling for biobanking. Pre-operative sarcopenia status is classified according to EWGSOP2 thresholds for grip strength and appendicular lean mass by DXA (Visit 3), complemented by quantitative MRI (Visit 3) of the quadriceps to detect fatty infiltration that DXA may miss. All imageries will be performed either few days before or after the hip replacement for limited biais.
During the arthroplasty (Visit 2) a micro-biopsy of the gluteus medius is obtained through the surgical approach without additional incision, and bone-cartilage and synovium, normally discarded are collected and immediately transferred on ice to INSERM U1046 or U1183 for conditionning for cell culture, mechanistic assays and long-term storage (with participant opt-in for the biological collection). Within 15 days post-operatively (Visit 3) each participant undergoes a high-resolution quadriceps MRI and low-dose DXA to finalise muscle characterisation and obtain bone density. Telephone follow-ups at 3 months (Visit 4) and 6 months (Visit 5) repeat the Barthel Index and capture complications, readmissions and living arrangements; additional geriatric assessment is offered if recovery is unsatisfactory as part of routine care.
The primary endpoint is the variation in Barthel Index between baseline, 3 months, and 6 months. Key secondary analyses relate pre-operative sarcopenia metrics to: (i) in-vitro myoblast regeneration and endocrine function of skeletal muscle; (ii) circulating concentrations of muscle biomarkers (e.g. myostatin, follistatin, irisin, IL-6, IGF-1, lactate) ; and (iii) MRI-derived quadriceps composition. Laboratory procedures follow standardised culture and imaging protocols and include quality-controlled quantification of muscle satellite-cell (MuSC) proliferation, differentiation and senescence markers, as well as endocrine function including extracellular vesicle composition analysis, histological scoring of cartilage explants, and chondrocyte phenotypes and mesenchymal stem cells multipotency.
All data are entered into an electronic case-report form with automated range and consistency checks; monitoring is performed by the CHU Montpellier sponsor through on-site visits, central statistical surveillance and adherence to French Jardé Category-1 regulations (biopsy constitutes the main additional intervention). The statistical analysis plan, finalised before database lock, prespecifies descriptive statistics, non-parametric tests (Wilcoxon-Mann-Whitney, Fisher) for the primary endpoint, and exploratory Spearman correlations between sarcopenia measures, regenerative indices and functional change; given the pilot nature, 95 % confidence intervals will be reported without formal p-values.
Adverse events related to additional procedures are expected to be minimal (venepuncture, MRI without ionising radiation, DXA ≈0.001 mSv, and intra-operative muscle biopsy performed under the same anaesthesia). All events will be captured and reported according to Good Clinical Practice; a data-safety officer affiliated with the institutional vigilance unit will review safety quarterly. The study duration per participant is six months; the overall project, including analysis and dissemination, spans 18 months. Results, positive, negative or inconclusive, will be submitted to peer-reviewed journals and uploaded to ClinicalTrials.gov within one year of completion, in line with French and EU transparency requirements. By integrating in-vivo phenotyping, advanced imaging and ex-vivo regenerative testing across two complementary hip-surgery models, Hip-REGEN should generate mechanistic hypotheses and candidate biomarkers to guide future stratified rehabilitation or pre-habilitation trials in sarcopenic older adults.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery | Experimental | Procedure: Total hip replacement, Biological: Blood sampling, Biological: Muscle biopsies, Biological: Collection of joint samples derived from surgical waste, Radiation: DXA, Other: MRI, Other: Handgrip strength test |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly subjects undergoing surgical hip replacement for fracture of the upper end of the femur or severe hip osteoarthritis.
Key exclusion criteria (11 listed)
- Contraindications to MRI : pacemaker, metallic implants.
- Presence of a lower-limb prosthesis on the contralateral side to the surgery that may interfere with quadriceps mass measurements.
- Progressive high-grade neoplasia.
- Documented major cognitive disorders
- Under legal protection measures (guardianship, conservatorship, or curatorship).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip replacementHip replacement is a surgical procedure performed as part of routine care for patients with a fracture of the upper end of the femur or severe osteoarthritis of the hip. | Procedure or surgery | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| Blood samplingFour heparinized tubes of 5 ml of blood will be collected from each patient at inclusion. All blood samples will be stored in a biobank for subsequent analyses targeting biomarkers potentially associated with sarcopenia and muscle regeneration. | Biological | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| Muscle biopsiesPerformed during hip arthroplasty | Biological | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| Collection of joint samples derived from surgical wastePerformed during hip arthroplasty | Biological | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| DXAWithin 15 days following the surgical procedure, during hospitalization/rehabilitation | Radiation | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| MRIWithin 15 days following the surgical procedure, during hospitalization/rehabilitation | Other | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
| Handgrip strength testMeasurement of handgrip strength using a hand dynamometer | Other | Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery |
Primary outcome
Change from Baseline in the Barthel Index at 3 months post-operative
Time frame: Baseline and 3 months
A 10-point shift is the minimal clinically important difference; after hip-fracture surgery a mean 25-point decline at 3 months is anticipated.
Change from Baseline in the Barthel Index at 6 months post-operative
Time frame: Baseline and 6 months
Measurement of hand-grip strength via dynamometry
Time frame: Baseline
Assessment of preoperative sarcopenia severity
Measurement of appendicular lean mass by DXA
Time frame: Prior to surgery or within 7 days postoperatively
Assessment of preoperative sarcopenia severity
Measurement of quadriceps mass by MRI
Time frame: Prior to surgery or within 7 days postoperatively
Assessment of preoperative sarcopenia severity. Because DXA cannot differentiate intramuscular fat or connective tissue, 3-D Dixon/IDEAL MRI of the quadriceps-the muscle most affected by ageing-will segment contractile tissue and compute muscle mass (volume × 1.04 kg · L-¹).
16 secondary outcomes
Number of myoblastic progenitors at proliferation onset
Time frame: Intraoperative
Mean myotube surface area at differentiation end
Time frame: Intraoperative
Proportion of senescent MSCs
Time frame: Intraoperative
Number of chondrocytes obtained from MSCs at differentiation end
Time frame: Intraoperative
Number of adipocytes obtained from MSCs at differentiation end
Time frame: Intraoperative
Number of osteocytes obtained from MSCs at differentiation end.
Time frame: Intraoperative
Serum concentation of myostatin
Time frame: Baseline and 3 month
Serum concentation of myostatin
Time frame: Baseline and 6 month
Serum concentation of follistatin
Time frame: Baseline and 3 month
Serum concentation of follistatin
Time frame: Baseline and 6 month
Serum concentation of irisin
Time frame: Baseline and 3 month
Serum concentation of irisin
Time frame: Baseline and 6 month
Serum concentation of IL-6
Time frame: Baseline and 3 month
Serum concentation of IL-6
Time frame: Baseline and 6 month
Serum concentation of IGF-1
Time frame: Baseline and 3 month
Serum concentation of IGF-1
Time frame: Baseline and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 37675071GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
- Background: PubMed 12502201Stein H, Perren SM, Cordey J, Kenwright J, Mosheiff R, Francis MJ. The muscle bed--a crucial factor for fracture healing: a physiological concept. Orthopedics. 2002 Dec;25(12):1379-83. doi: 10.3928/0147-7447-20021201-16. No abstract available.
- Background: PubMed 22473333Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49.
- Background: PubMed 29214748Brzeszczynska J, Meyer A, McGregor R, Schilb A, Degen S, Tadini V, Johns N, Langen R, Schols A, Glass DJ, Roubenoff R, Ross JA, Fearon KCH, Greig CA, Jacobi C. Alterations in the in vitro and in vivo regulation of muscle regeneration in healthy ageing and the influence of sarcopenia. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):93-105. doi: 10.1002/jcsm.12252. Epub 2017 Dec 6.
- Background: PubMed 10663356Fox KM, Magaziner J, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R. Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000;11(1):31-5. doi: 10.1007/s001980050003.
- Background: PubMed 17885314Di Monaco M, Vallero F, Di Monaco R, Tappero R, Cavanna A. Muscle mass and functional recovery in men with hip fracture. Am J Phys Med Rehabil. 2007 Oct;86(10):818-25. doi: 10.1097/PHM.0b013e318151fec7.
- Background: PubMed 23989253Maden-Wilkinson TM, Degens H, Jones DA, McPhee JS. Comparison of MRI and DXA to measure muscle size and age-related atrophy in thigh muscles. J Musculoskelet Neuronal Interact. 2013 Sep;13(3):320-8.
- Background: PubMed 36967049Fuchs CJ, Kuipers R, Rombouts JA, Brouwers K, Schrauwen-Hinderling VB, Wildberger JE, Verdijk LB, van Loon LJC. Thigh muscles are more susceptible to age-related muscle loss when compared to lower leg and pelvic muscles. Exp Gerontol. 2023 May;175:112159. doi: 10.1016/j.exger.2023.112159. Epub 2023 Mar 31.
- Background: PubMed 25425462Vergara I, Vrotsou K, Orive M, Gonzalez N, Garcia S, Quintana JM. Factors related to functional prognosis in elderly patients after accidental hip fractures: a prospective cohort study. BMC Geriatr. 2014 Nov 26;14:124. doi: 10.1186/1471-2318-14-124.
- Background: PubMed 37348597Gielen E, Dupont J, Dejaeger M, Laurent MR. Sarcopenia, osteoporosis and frailty. Metabolism. 2023 Aug;145:155638. doi: 10.1016/j.metabol.2023.155638. Epub 2023 Jun 20.
- Background: PubMed 20207030Di Monaco M, Vallero F, Di Monaco R, Tappero R. Prevalence of sarcopenia and its association with osteoporosis in 313 older women following a hip fracture. Arch Gerontol Geriatr. 2011 Jan-Feb;52(1):71-4. doi: 10.1016/j.archger.2010.02.002. Epub 2010 Mar 5.
- BackgroundHaute Autorité de Santé. Prothèses de hanche. Saint-Denis La Plaine: HAS; 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement, Blood sampling and Muscle biopsies in people with Sarcopenia in Elderly and Osteoarthritis (OA), run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Baptiste ROBIAUD, Assistant head physician (+33629184092, jbrobiaud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Barthel Index at 3 months post-operative (time frame: Baseline and 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07429955, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.