Hip OsteoarthritisPROHIPNCT04070027
Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis
A study testing Total Hip Arthroplasty and Progressive Resistance Training in people with Hip Osteoarthritis, run by Vejle Hospital at 4 sites in Denmark.
Trial summary
Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Total Hip Arthroplasty and Progressive Resistance Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 4 sitesDenmark
- Study dates
- 2 Sep 2019to Dec 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥50 years
- Clinical history and symptoms consistent with primary hip osteoarthritis (including hip osteoarthritis due to mild hip dysplasia that may be treated with standard components) and radiographic verified hip osteoarthritis defined as joint space narrowing <2 mm
- Considered eligible for total hip arthroplasty by an orthopaedic surgeon (i.e. duration of symptoms >3 months, hip related pain, functional impairment or decreased range of motion (ROM), and attempted treatment with analgesics)
Who cannot join
- Severe walking deficits (dependency of two crutches or walker)
- Body Mass Index >35 kg/m2
- Lower extremity fractures within one-year prior to inclusion
- Planned other lower extremity surgery within six months
- Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
- Neurological diseases (e.g. previous stroke, multiple sclerosis, Parkinson's, Alzheimer's).
- Other reasons for exclusion (i.e. inadequacy in written and spoken Danish, mentally unable to participate, physically unable to comply with the PRT protocol due to comorbidity (e.g. severe heart disease, previous major lower extremity surgery within six-months) etc.).
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Department of Orthopaedic Surgery, Aarhus University Hospital (AUH)
Aarhus, 8200
Department of Orthopaedic Surgery, Naestved Hospital
Næstved, 4700
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital (OUH)
Odense, 5000
Depatment of Orthopaedic Surgery, Vejle Hospital
Vejle, 7100
About this study
Official title: Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With End-stage Hip Osteoarthritis (PROHIP): A Multicentre, Parallel-group, Randomised Controlled Superiority Trial
Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip osteoarthritis. This comparison is of upmost importance as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The purpose of this study is to investigate whether total hip arthroplasty followed by standard care is superior to progressive resistance training for improving hip function and pain in patients with end-stage hip osteoarthritis.
The hypothesis is that patients treated with total hip arthroplasty will improve more than patients treated with progressive resistance training.
Read the detailed description
Hip osteoarthritis (OA) is associated with joint pain, dysfunction of activities of daily living (ADL), decreased muscle strength and decline in health-related quality of life status, and the most common cause for total hip arthroplasty (THA). In Denmark, approximately 10.400 primary THA surgeries are performed annually, and the yearly incidence rate of this procedure has increased dramatically from 80 to 180 per 100.000 persons between 1995 and 2016. However, some patients experience long-term pain and may never recover full physical function and muscle strength after surgery.
Exercise has been shown to improve physical function and reduce pain in people with hip OA, and is recommended initially as a treatment in international clinical guidelines. Furthermore, a recent randomised controlled trial (RCT) showed clinically relevant improvements in ADL and muscle function after 10-weeks of supervised explosive-type progressive resistance training (PRT) in patients with end-stage hip OA scheduled for THA compared to standard preoperative care.
To date, no RCTs have investigated the effect of THA followed by standard postoperative care compared to supervised explosive-type PRT in patients with end-stage hip OA. Therefore, this highlights the need for a high-quality trial as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The aim of this randomised controlled trial is to investigate whether THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the Oxford Hip Score (OHS), in patients with end-stage hip OA eligible for THA. Exploratory outcome time-points will be assessed at 3, 12, 24 and 60 months after initiating the intervention.
The hypothesis is that THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the OHS, in patients with end-stage hip OA eligible for THA.
Observational cohort:
Patients fulfilling the eligibility criteria but declining to participate in the RCT will be asked to participate in a prospective observational cohort study using the same primary end-point (6 months), exploratory time-points (3, 12, 24 and 60 months), and patient-reported outcomes, but following usual clinical practice.
- Conditions
- Hip Osteoarthritis
- Being tested
- Total Hip Arthroplasty, Progressive Resistance Training
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Exercise, Progressive Resistance Training, Strength Training, Hip Joint
- Medical subject headings
- Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Also called Total Hip Replacement
Total hip arthroplasty following standard procedures.
Progressive Resistance TrainingOther
Also called Strength Training, Exercise
Progressive resistance training based on available evidence on patients with hip osteoarthritis and designed in accordance with the "American College of Sports Medicine" (ACSM) recommendations for progression models in resistance training aiming at inducing muscle hypertrophy and increasing muscle strength and power.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty | Active comparator | A standard fast-track multimodal surgical program comprising patient information, optimised pain management, and early mobilisation. Total hip arthroplasty (THA) will be performed by experienced orthopaedic surgeons in accordance with the standard posterior surgical approach. Patients will receive standard postoperative rehabilitation consisting of either a standard leaflet with a hospital-specific home-based exercise program aimed at increasing hip muscle strength and range of motion or, if considered necessary, a referral to supervised hip-specific exercise therapy delivered at private physiotherapist clinics or municipal rehabilitation. Furthermore, postsurgical procedures will follow hospital-specific procedures ranging from no postsurgical control to postsurgical assessment of the hip and rehabilitation at the physiotherapy department (after six-weeks). Receives: Procedure: Total Hip Arthroplasty |
| Progressive Resistance Training | Active comparator | A 12-week supervised explosive-type progressive resistance training (PRT) program with two training sessions a week. All training sessions will be conducted in municipal rehabilitation centres with one-to-one supervision and ≥48 hours of rest in between sessions. The standardised PRT program will consist of warm-up on a stationary bicycle (10 min) followed by four lower extremity exercises (50 min). Exercises will be performed unilaterally with as full range of motion as possible in sets of three separated by 60 sec of rest in the following order: leg press, hip extension, hip flexion, and hip abduction. Patients will be instructed to complete the concentric phase of each repetition "as fast as possible", maintain full extension for 1 sec, and perform the eccentric phase in 2-3 sec. Hip-related pain up to 5 rated on a Numerical Rating Scale (0-10) is considered acceptable during exercises. After the 12-weeks, patients will be offered three-months of optional unsupervised PRT. Receives: Other: Progressive Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oxford Hip Score (OHS) from baseline to 6 months
The OHS is a 12-item patient-reported outcome measure designed to assess hip function and pain within the last four weeks among patients suffering from hip osteoarthritis in one score. The total score ranges from 0 to 48, with higher scores indicating better disease status.
Measured: 6 months
Secondary outcomes (9)
Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale from baseline to 6 months
The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status.
Measured: 6 months
Change in the HOOS symptoms subscale from baseline to 6 months
The HOOS pain subscale is a five-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status.
Measured: 6 months
Change in the HOOS activities of daily living (ADL) function subscale from baseline to 6 months
The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Measured: 6 months
Change in the HOOS quality-of-life subscale from baseline to 6 months
The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Measured: 6 months
Change in the HOOS sports and recreation subscale from baseline to 6 months
The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status.
Measured: 6 months.
Change in the University of California Los Angeles (UCLA) Activity Score
The UCLA Activity Score is a single-item patient-reported outcome measure designed to assess physical activity level. The score ranges from 1 to 10, with higher scores indicating greater physical activity level.
Measured: 6 months
Change in the 40 metre Fast Paced Walk Test (40m-FPWT) from baseline to 6 months
The 40m-FPWT is a physical function test designed to assess short distance maximum walking speed (meters/second).
Measured: 6 months
Change in the 30 second Chair Stand Test (30s-CST) from baseline to 6 months
The 30s-CST is a physical function test designed to assess sit-to-stand function (number of repetitions).
Measured: 6 months
Number of Serious Adverse Events (SAE) from baseline to 6 months
SAE according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines will be collected from The Danish National Patient Registry and medical record review conducted at the 6 months follow-up. Furthermore, a short patient-reported questionnaire at the 3 and 6 months follow-up will be used to ensure that all SAE are recorded.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Sep 2019
- Primary completion5 May 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Naestved Hospital, Aarhus University Hospital, The Danish Rheumatism Association, Region of Southern Denmark, Association of Danish Physiotherapists, The Research Council at Naestved-Slagelse-Ringsted Hospitals
- Responsible party
- Sponsor
- Investigators
- Thomas Frydendal, PT, MSc, Principal investigator, University of Southern DenmarkSøren Overgaard, Prof., MD, Study director, Odense University Hospital and University of Southern DenmarkInger Mechlenburg, Prof., DMSc, Study chair, Aarhus University Hospital and Aarhus UniversityKim Gordon Ingwersen, PT, PhD, Study chair, University of Southern DenmarkLone Ramer Mikkelsen, PT, PhD, Study chair, Silkeborg Regional HospitalRobin Christensen, Prof., PhD, Study chair, The Parker Institute and Odense University HospitalClaus Varnum, PhD, MD, Study chair, Vejle HospitalHenrik Morville Schrøder, PhD, MD, Study chair, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070027
- Sponsor's protocol ID
- S-20180158
- Other IDs
- R153-A4771, R161-A5280, R166-A5553, R176-A6231, 18/41994, 17/33622
- Acronym
- PROHIP
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2019
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
Publications
Bryld ES, Christiansen L, Ingwersen KG, Overgaard S, Mikkelsen LR, Mechlenburg I, Frydendal T. Training load and pain response during progressive resistance training in patients with hip osteoarthritis in the PROHIP trial. Osteoarthr Cartil Open. 2025 Oct 4;7(4):100690. doi: 10.1016/j.ocarto.2025.100690. eCollection 2025 Dec.
PubMed 41141645Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Varnum C, Graversen AE, Kjaersgaard-Andersen P, Revald PH, Hofbauer C, Bieder MJ, Qassim H, Munir MS, Jakobsen SS, Nielsen SM, Ingwersen KG, Overgaard S. Total Hip Replacement or Resistance Training for Severe Hip Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1610-1620. doi: 10.1056/NEJMoa2400141.
PubMed 39476341Frydendal T, Thomsen KS, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG, Myburgh C. Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study. BMJ Open. 2023 Apr 24;13(4):e070866. doi: 10.1136/bmjopen-2022-070866.
PubMed 37094895Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG. Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial. BMJ Open. 2021 Oct 22;11(10):e051392. doi: 10.1136/bmjopen-2021-051392.
PubMed 34686555
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With End-stage Hip Osteoarthritis (PROHIP): A Multicentre, Parallel-group, Randomised Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT04070027
- Acronym / sponsor ID
- PROHIP / S-20180158
- Conditions
- Hip Osteoarthritis
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Exercise, Progressive Resistance Training, Strength Training, Hip Joint
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Naestved Hospital, Aarhus University Hospital, The Danish Rheumatism Association, Region of Southern Denmark, Association of Danish Physiotherapists, The Research Council at Naestved-Slagelse-Ringsted Hospitals
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Aug 2019 (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.
Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip osteoarthritis. This comparison is of upmost importance as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The purpose of this study is to investigate whether total hip arthroplasty followed by standard care is superior to progressive resistance training for improving hip function and pain in patients with end-stage hip osteoarthritis.
The hypothesis is that patients treated with total hip arthroplasty will improve more than patients treated with progressive resistance training.
Detailed description
Hip osteoarthritis (OA) is associated with joint pain, dysfunction of activities of daily living (ADL), decreased muscle strength and decline in health-related quality of life status, and the most common cause for total hip arthroplasty (THA). In Denmark, approximately 10.400 primary THA surgeries are performed annually, and the yearly incidence rate of this procedure has increased dramatically from 80 to 180 per 100.000 persons between 1995 and 2016. However, some patients experience long-term pain and may never recover full physical function and muscle strength after surgery.
Exercise has been shown to improve physical function and reduce pain in people with hip OA, and is recommended initially as a treatment in international clinical guidelines. Furthermore, a recent randomised controlled trial (RCT) showed clinically relevant improvements in ADL and muscle function after 10-weeks of supervised explosive-type progressive resistance training (PRT) in patients with end-stage hip OA scheduled for THA compared to standard preoperative care.
To date, no RCTs have investigated the effect of THA followed by standard postoperative care compared to supervised explosive-type PRT in patients with end-stage hip OA. Therefore, this highlights the need for a high-quality trial as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The aim of this randomised controlled trial is to investigate whether THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the Oxford Hip Score (OHS), in patients with end-stage hip OA eligible for THA. Exploratory outcome time-points will be assessed at 3, 12, 24 and 60 months after initiating the intervention.
The hypothesis is that THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the OHS, in patients with end-stage hip OA eligible for THA.
Observational cohort:
Patients fulfilling the eligibility criteria but declining to participate in the RCT will be asked to participate in a prospective observational cohort study using the same primary end-point (6 months), exploratory time-points (3, 12, 24 and 60 months), and patient-reported outcomes, but following usual clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty | Active comparator | Procedure: Total Hip ArthroplastyA standard fast-track multimodal surgical program comprising patient information, optimised pain management, and early mobilisation. Total hip arthroplasty (THA) will be performed by experienced orthopaedic surgeons in accordance with the standard posterior surgical approach. Patients will receive standard postoperative rehabilitation consisting of either a standard leaflet with a hospital-specific home-based exercise program aimed at increasing hip muscle strength and range of motion or, if considered necessary, a referral to supervised hip-specific exercise therapy delivered at private physiotherapist clinics or municipal rehabilitation. Furthermore, postsurgical procedures will follow hospital-specific procedures ranging from no postsurgical control to postsurgical assessment of the hip and rehabilitation at the physiotherapy department (after six-weeks). |
| Progressive Resistance Training | Active comparator | Other: Progressive Resistance TrainingA 12-week supervised explosive-type progressive resistance training (PRT) program with two training sessions a week. All training sessions will be conducted in municipal rehabilitation centres with one-to-one supervision and ≥48 hours of rest in between sessions. The standardised PRT program will consist of warm-up on a stationary bicycle (10 min) followed by four lower extremity exercises (50 min). Exercises will be performed unilaterally with as full range of motion as possible in sets of three separated by 60 sec of rest in the following order: leg press, hip extension, hip flexion, and hip abduction. Patients will be instructed to complete the concentric phase of each repetition "as fast as possible", maintain full extension for 1 sec, and perform the eccentric phase in 2-3 sec. Hip-related pain up to 5 rated on a Numerical Rating Scale (0-10) is considered acceptable during exercises. After the 12-weeks, patients will be offered three-months of optional unsupervised PRT. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥50 years
- Clinical history and symptoms consistent with primary hip osteoarthritis (including hip osteoarthritis due to mild hip dysplasia that may be treated with standard components) and radiographic verified hip osteoarthritis defined as joint space narrowing <2 mm
- Considered eligible for total hip arthroplasty by an orthopaedic surgeon (i.e. duration of symptoms >3 months, hip related pain, functional impairment or decreased range of motion (ROM), and attempted treatment with analgesics)
Key exclusion criteria (7 listed)
- Severe walking deficits (dependency of two crutches or walker)
- Body Mass Index >35 kg/m2
- Lower extremity fractures within one-year prior to inclusion
- Planned other lower extremity surgery within six months
- Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
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 ArthroplastyAlso: Total Hip ReplacementTotal hip arthroplasty following standard procedures. | Procedure or surgery | Total Hip Arthroplasty |
| Progressive Resistance TrainingAlso: Strength Training, ExerciseProgressive resistance training based on available evidence on patients with hip osteoarthritis and designed in accordance with the "American College of Sports Medicine" (ACSM) recommendations for progression models in resistance training aiming at inducing muscle hypertrophy and increasing muscle strength and power. | Other | Progressive Resistance Training |
Primary outcome
Change in the Oxford Hip Score (OHS) from baseline to 6 months
Time frame: 6 months
The OHS is a 12-item patient-reported outcome measure designed to assess hip function and pain within the last four weeks among patients suffering from hip osteoarthritis in one score. The total score ranges from 0 to 48, with higher scores indicating better disease status.
9 secondary outcomes
Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale from baseline to 6 months
Time frame: 6 months
Change in the HOOS symptoms subscale from baseline to 6 months
Time frame: 6 months
Change in the HOOS activities of daily living (ADL) function subscale from baseline to 6 months
Time frame: 6 months
Change in the HOOS quality-of-life subscale from baseline to 6 months
Time frame: 6 months
Change in the HOOS sports and recreation subscale from baseline to 6 months
Time frame: 6 months.
Change in the University of California Los Angeles (UCLA) Activity Score
Time frame: 6 months
Change in the 40 metre Fast Paced Walk Test (40m-FPWT) from baseline to 6 months
Time frame: 6 months
Change in the 30 second Chair Stand Test (30s-CST) from baseline to 6 months
Time frame: 6 months
Number of Serious Adverse Events (SAE) from baseline to 6 months
Time frame: 6 months.
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 21 Aug 2026.
- Derived from this study: PubMed 41141645Bryld ES, Christiansen L, Ingwersen KG, Overgaard S, Mikkelsen LR, Mechlenburg I, Frydendal T. Training load and pain response during progressive resistance training in patients with hip osteoarthritis in the PROHIP trial. Osteoarthr Cartil Open. 2025 Oct 4;7(4):100690. doi: 10.1016/j.ocarto.2025.100690. eCollection 2025 Dec.
- Derived from this study: PubMed 39476341Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Varnum C, Graversen AE, Kjaersgaard-Andersen P, Revald PH, Hofbauer C, Bieder MJ, Qassim H, Munir MS, Jakobsen SS, Nielsen SM, Ingwersen KG, Overgaard S. Total Hip Replacement or Resistance Training for Severe Hip Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1610-1620. doi: 10.1056/NEJMoa2400141.
- Derived from this study: PubMed 37094895Frydendal T, Thomsen KS, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG, Myburgh C. Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study. BMJ Open. 2023 Apr 24;13(4):e070866. doi: 10.1136/bmjopen-2022-070866.
- Derived from this study: PubMed 34686555Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG. Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial. BMJ Open. 2021 Oct 22;11(10):e051392. doi: 10.1136/bmjopen-2021-051392.
- Individual participant dataSharing planned: Yes. Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
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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. This study is not recruiting at the moment.
Thomas Frydendal, PT, MSc principal investigator
University of Southern Denmark
Søren Overgaard, Prof., MD study director
Odense University Hospital and University of Southern Denmark
Inger Mechlenburg, Prof., DMSc study chair
Aarhus University Hospital and Aarhus University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty and Progressive Resistance Training in people with Hip Osteoarthritis, run by Vejle Hospital at 4 sites in Denmark.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Oxford Hip Score (OHS) from baseline to 6 months (time frame: 6 months). 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 NCT04070027, which also lists 4 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 21 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.