OrthopedicESPI-PRONCT06734845
Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes
An observational study of Orthopedic and Osteo Arthritis Knee, run by University of Connecticut at 1 site in United States.
Trial summary
The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic, Osteo Arthritis Knee, Hip Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty and Total Joint Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults aged 50-70 yrs undergoing first elective total joint arthroplasty for hip or knee.
Who may be able to join
- Body Mass Index (BMI) between 18.5-34.9 kg/m2; receiving elective total hip or knee arthroplasty due to osteoarthritis for first time
Who cannot join
- Patients with any non-orthopedic impairment that can impact lower extremity function or mobility, such as paralysis, stroke, multiple sclerosis, and spinal cord injury
- Post-enrollment exclusion criteria (if applicable)
- For Aim 2:
- Patients who do not attend post-operative physical therapy at one of the identified locations (please see section: Project Personnel)
- Patients who are non-compliant with their physical therapy prescription (missing four or more scheduled sessions).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hartford Hospital Bone & Joint Institute
Hartford, Connecticut, 06102
About this study
The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures.
Study Aims. Specific aims and their respective approach for the proposed investigation were:
Read more
Aim 1: Characterize energy status and protein intake in total hip arthroplasty and total knee arthroplasty patients prior to surgery.
Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery.
Aim 2: Evaluate association between energy status, positive or negative energy balance on standard outcome measures assessed throughout physical rehabilitation to determine whether energy status and protein intake at admission predicts objective and subjective rehabilitative outcome measures. Dietary assessments (3-day food record, protein screener) occurred at time points corresponding to physical rehabilitative assessments per approach for Aim 1.
Approach. Total Hip Replacement assessments will occur between Day 1 following surgery and Week 2 and 6 months post surgery . Outcome measures included Pain Visual Analog Scale, Hip Disability Osteoarthritis Outcome Score, Timed Up and Go Test, 30 second Sit to Stand Test, Passive Hip Range of Motion and Active Hip Range of Motion.
Total knee assessments were taken post surgery on between Day 1 and Week 2 and at 4 to 6 Weeks, and 7 to 12 Weeks following surgery. These included Pain Visual Analog Scale, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go test, 30-second Sit to Stand Test, Passive and Active Knee Range of Motion, and Knee Strength.
Aim 3: Validate a protein screener developed by our research team and designed to characterize protein intake and protein source was administered pre- and post-operatively.
For the latter, time points were established according to respective treatment guidelines for Total Hip and Total Knee replacement patients, respectively.
Read the detailed description
Clinical Significance: The clinical relevance of the proposed project is the eventual development of evidence-based rehabilitative nutrition practice guidelines for orthopedic patients. The scientific literature specific to the role of perioperative nutrition on rehabilitative outcomes in patients undergoing elective total joint procedures, total hip arthroplasty and total knee arthroplasty in particular, is limited.
Background and Study Rationale. Orthopedic procedures are commonly undergone to treat injuries and chronic conditions affecting the hip and knee. Primary arthroplasties represented 86% of the 1.9 million hip and knee arthroplasties performed in the United States from 2012-2019. Total hip and total knee replacement procedures are typical in older men and women and persistent muscle loss is a shared clinical presentation for young as well as older individuals undergoing elective orthopedic surgery procedures. Energy status energy status and protein intake, nutrition factors known to affect muscle mass and strength in orthopedic patients, has not been characterized prior to admission. Whether this aspect of nutritional status might predict recovery of muscle mass, strength, and function in the context of standard practice/post-operative rehabilitative treatment guidelines is not known.
Elective orthopedic surgery patients face major challenges in maintaining muscle mass and function during the perioperative period. Patients receiving protein or essential amino acid supplementation following total hip and total knee replacement, show improvements in protein balance, patient reported outcome measures, as well as muscle mass, strength, and function. Investigations of larger sample size and longer study duration where protein intake is adequately characterized prior to surgery are needed in these patient populations to further determine connections between routine protein intake and post-operative muscle specific outcomes. Perioperative nutrition screening and assessment measures specifically tailored to orthopedic patients that are attentive to energy status and protein intake are needed. The development and validation of the protein screener proposed in for this project is a unique approach to efficiently acquiring valuable perioperative dietary information. Including subjective, as well as functional, outcome measures may reveal associations between energy status and dietary protein intake pre-operatively and rehabilitative outcomes specific to muscle health to support routine assessment of these dietary factors as prognostic indicators for patient recovery following total hip and total arthroplasty. The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (i.e., strength and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures.
Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery. Recruitment was done in collaboration with the perioperative program staff. Eligible patients and a member of the research team met with patients to determine interest, review study requirements, and obtain written, informed consent for study enrollment. Dietary assessments (protein screener and 3-day food record) occurred before and after surgery per treatment guidelines for total hip and total knee replacement patients, respectively. The protein screener was designed to characterize protein intake and protein source and the respective 3-day food record for participants was used to validate patient responses on screener. Routine clinical assessments per treatment guidelines for respective patient populations were done.
Statistical Approach. Means and standard deviations were determined for outcome measures. Data was analyzed using a 3 factor (energy status, protein intake, and rehabilitative outcome measures) repeated measures over time analysis of variance. Post hoc tests were applied where statistical significance is noted; alpha-level was set at P< 0.05.
- Conditions
- Orthopedic, Osteo Arthritis Knee, Hip Osteoarthritis, Protein-Energy Malnutrition, Energy Malnutrition Protein
- Being tested
- Total Knee Arthroplasty, Total Joint Arthroplasty
- Keywords
- Joint replacement, Rehabilitation, Protein, Energy Balance, Knee arthroplasty, Hip arthroplasty, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip, Protein-Energy Malnutrition, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called Total Hip Arthroplasty
Total Joint (Knee or Hip) Arthroplasty
Total Joint ArthroplastyProcedure or surgery
Participants will be patients undergoing first total knee or total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Patients undergoing first total knee replacement Receives: Procedure: Total Knee Arthroplasty | |
| Total Hip Arthroplasty | Patients undergoing first total hip replacement Receives: Procedure: Total Joint Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Intake
Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)
Measured: Protein intake will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients
Protein Intake
Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)
Measured: Protein intake will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients
Secondary outcomes (2)
Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and energy expenditure)
Energy balance is determined as difference between calories estimated for energy expenditure and calories consumed. Energy intake will be determined from the 3 day food records provide by study participants and energy expenditure will be estimated using the Mifflin-St. Jeor predictive equation plus calories estimated using respective activity factors for participating subjects.
Measured: Energy balance/status will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients.
Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and estimates of energy expenditure)
Energy balance is determined as difference between calories estimated for energy expenditure and calories consumed. Energy intake will be determined from the 3 day food records provide by study participants and energy expenditure will be estimated using the Mifflin-St. Jeor predictive equation plus calories estimated using respective activity factors for participating subjects.
Measured: Energy balance/status will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Jan 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OrthopedicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Rodriguez, University of Connecticut
- Investigators
- Nancy R Rodriguez, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734845
- Sponsor's protocol ID
- HHC-2022-0261
- Acronym
- ESPI-PRO
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.
PubMed 20851566Howard EE, Pasiakos SM, Fussell MA, Rodriguez NR. Skeletal Muscle Disuse Atrophy and the Rehabilitative Role of Protein in Recovery from Musculoskeletal Injury. Adv Nutr. 2020 Jul 1;11(4):989-1001. doi: 10.1093/advances/nmaa015.
PubMed 32167129Howard EE, Margolis LM, Fussell MA, Rios CG, Meisterling EM, Lena CJ, Pasiakos SM, Rodriguez NR. Effect of High-Protein Diets on Integrated Myofibrillar Protein Synthesis before Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Pilot Study. Nutrients. 2022 Jan 27;14(3):563. doi: 10.3390/nu14030563.
PubMed 35276922Church DD, Schutzler SE, Wolfe RR, Ferrando AA. Perioperative amino acid infusion reestablishes muscle net balance during total hip arthroplasty. Physiol Rep. 2021 Sep;9(18):e15055. doi: 10.14814/phy2.15055.
PubMed 34558214Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
PubMed 29369092Dreyer HC, Owen EC, Strycker LA, Smolkowski K, Muyskens JB, Kirkpatrick TK, Christie AD, Kuehl KS, Lantz BA, Shah SN, Mohler CG, Jewett BA. Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. JB JS Open Access. 2018 Jun 4;3(2):e0006. doi: 10.2106/JBJS.OA.18.00006. eCollection 2018 Jun 28.
PubMed 30280129Dreyer HC, Strycker LA, Senesac HA, Hocker AD, Smolkowski K, Shah SN, Jewett BA. Essential amino acid supplementation in patients following total knee arthroplasty. J Clin Invest. 2013 Nov;123(11):4654-66. doi: 10.1172/JCI70160. Epub 2013 Oct 25.
PubMed 24135139Kouw IWK, Groen BBL, Smeets JSJ, Kramer IF, van Kranenburg JMX, Nilwik R, Geurts JAP, Ten Broeke RHM, Poeze M, van Loon LJC, Verdijk LB. One Week of Hospitalization Following Elective Hip Surgery Induces Substantial Muscle Atrophy in Older Patients. J Am Med Dir Assoc. 2019 Jan;20(1):35-42. doi: 10.1016/j.jamda.2018.06.018. Epub 2018 Aug 11.
PubMed 30108034Dutaillis B, Maniar N, Opar DA, Hickey JT, Timmins RG. Lower Limb Muscle Size after Anterior Cruciate Ligament Injury: A Systematic Review and Meta-Analysis. Sports Med. 2021 Jun;51(6):1209-1226. doi: 10.1007/s40279-020-01419-0. Epub 2021 Jan 25.
PubMed 33492623
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes
- ClinicalTrials.gov ID
- NCT06734845
- Acronym / sponsor ID
- ESPI-PRO / HHC-2022-0261
- Conditions
- Orthopedic, Osteo Arthritis Knee, Hip Osteoarthritis, Protein-Energy Malnutrition, Energy Malnutrition Protein
- Keywords
- Joint replacement, Rehabilitation, Protein, Energy Balance, Knee arthroplasty, Hip arthroplasty, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 16 Dec 2024 (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.
The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures.
Study Aims. Specific aims and their respective approach for the proposed investigation were:
Aim 1: Characterize energy status and protein intake in total hip arthroplasty and total knee arthroplasty patients prior to surgery.
Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery.
Aim 2: Evaluate association between energy status, positive or negative energy balance on standard outcome measures assessed throughout physical rehabilitation to determine whether energy status and protein intake at admission predicts objective and subjective rehabilitative outcome measures. Dietary assessments (3-day food record, protein screener) occurred at time points corresponding to physical rehabilitative assessments per approach for Aim 1.
Approach. Total Hip Replacement assessments will occur between Day 1 following surgery and Week 2 and 6 months post surgery . Outcome measures included Pain Visual Analog Scale, Hip Disability Osteoarthritis Outcome Score, Timed Up and Go Test, 30 second Sit to Stand Test, Passive Hip Range of Motion and Active Hip Range of Motion.
Total knee assessments were taken post surgery on between Day 1 and Week 2 and at 4 to 6 Weeks, and 7 to 12 Weeks following surgery. These included Pain Visual Analog Scale, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go test, 30-second Sit to Stand Test, Passive and Active Knee Range of Motion, and Knee Strength.
Aim 3: Validate a protein screener developed by our research team and designed to characterize protein intake and protein source was administered pre- and post-operatively.
For the latter, time points were established according to respective treatment guidelines for Total Hip and Total Knee replacement patients, respectively.
Detailed description
Clinical Significance: The clinical relevance of the proposed project is the eventual development of evidence-based rehabilitative nutrition practice guidelines for orthopedic patients. The scientific literature specific to the role of perioperative nutrition on rehabilitative outcomes in patients undergoing elective total joint procedures, total hip arthroplasty and total knee arthroplasty in particular, is limited.
Background and Study Rationale. Orthopedic procedures are commonly undergone to treat injuries and chronic conditions affecting the hip and knee. Primary arthroplasties represented 86% of the 1.9 million hip and knee arthroplasties performed in the United States from 2012-2019. Total hip and total knee replacement procedures are typical in older men and women and persistent muscle loss is a shared clinical presentation for young as well as older individuals undergoing elective orthopedic surgery procedures. Energy status energy status and protein intake, nutrition factors known to affect muscle mass and strength in orthopedic patients, has not been characterized prior to admission. Whether this aspect of nutritional status might predict recovery of muscle mass, strength, and function in the context of standard practice/post-operative rehabilitative treatment guidelines is not known.
Elective orthopedic surgery patients face major challenges in maintaining muscle mass and function during the perioperative period. Patients receiving protein or essential amino acid supplementation following total hip and total knee replacement, show improvements in protein balance, patient reported outcome measures, as well as muscle mass, strength, and function. Investigations of larger sample size and longer study duration where protein intake is adequately characterized prior to surgery are needed in these patient populations to further determine connections between routine protein intake and post-operative muscle specific outcomes. Perioperative nutrition screening and assessment measures specifically tailored to orthopedic patients that are attentive to energy status and protein intake are needed. The development and validation of the protein screener proposed in for this project is a unique approach to efficiently acquiring valuable perioperative dietary information. Including subjective, as well as functional, outcome measures may reveal associations between energy status and dietary protein intake pre-operatively and rehabilitative outcomes specific to muscle health to support routine assessment of these dietary factors as prognostic indicators for patient recovery following total hip and total arthroplasty. The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (i.e., strength and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures.
Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery. Recruitment was done in collaboration with the perioperative program staff. Eligible patients and a member of the research team met with patients to determine interest, review study requirements, and obtain written, informed consent for study enrollment. Dietary assessments (protein screener and 3-day food record) occurred before and after surgery per treatment guidelines for total hip and total knee replacement patients, respectively. The protein screener was designed to characterize protein intake and protein source and the respective 3-day food record for participants was used to validate patient responses on screener. Routine clinical assessments per treatment guidelines for respective patient populations were done.
Statistical Approach. Means and standard deviations were determined for outcome measures. Data was analyzed using a 3 factor (energy status, protein intake, and rehabilitative outcome measures) repeated measures over time analysis of variance. Post hoc tests were applied where statistical significance is noted; alpha-level was set at P< 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | – | Procedure: Total Knee ArthroplastyPatients undergoing first total knee replacement |
| Total Hip Arthroplasty | – | Procedure: Total Joint ArthroplastyPatients undergoing first total hip replacement |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults aged 50-70 yrs undergoing first elective total joint arthroplasty for hip or knee.
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) between 18.5-34.9 kg/m2; receiving elective total hip or knee arthroplasty due to osteoarthritis for first time
Key exclusion criteria (5 listed)
- Patients with any non-orthopedic impairment that can impact lower extremity function or mobility, such as paralysis, stroke, multiple sclerosis, and spinal cord injury
- Post-enrollment exclusion criteria (if applicable)
- Patients who do not attend post-operative physical therapy at one of the identified locations (please see section: Project Personnel)
- Patients who are non-compliant with their physical therapy prescription (missing four or more scheduled sessions).
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 Knee ArthroplastyAlso: Total Hip ArthroplastyTotal Joint (Knee or Hip) Arthroplasty | Procedure or surgery | Total Knee Arthroplasty |
| Total Joint ArthroplastyParticipants will be patients undergoing first total knee or total hip replacement | Procedure or surgery | Total Hip Arthroplasty |
Primary outcome
Protein Intake
Time frame: Protein intake will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients
Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)
Protein Intake
Time frame: Protein intake will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients
Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)
2 secondary outcomes
Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and energy expenditure)
Time frame: Energy balance/status will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients.
Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and estimates of energy expenditure)
Time frame: Energy balance/status will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 20851566Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.
- Background: PubMed 32167129Howard EE, Pasiakos SM, Fussell MA, Rodriguez NR. Skeletal Muscle Disuse Atrophy and the Rehabilitative Role of Protein in Recovery from Musculoskeletal Injury. Adv Nutr. 2020 Jul 1;11(4):989-1001. doi: 10.1093/advances/nmaa015.
- Background: PubMed 35276922Howard EE, Margolis LM, Fussell MA, Rios CG, Meisterling EM, Lena CJ, Pasiakos SM, Rodriguez NR. Effect of High-Protein Diets on Integrated Myofibrillar Protein Synthesis before Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Pilot Study. Nutrients. 2022 Jan 27;14(3):563. doi: 10.3390/nu14030563.
- Background: PubMed 34558214Church DD, Schutzler SE, Wolfe RR, Ferrando AA. Perioperative amino acid infusion reestablishes muscle net balance during total hip arthroplasty. Physiol Rep. 2021 Sep;9(18):e15055. doi: 10.14814/phy2.15055.
- Background: PubMed 29369092Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
- Background: PubMed 30280129Dreyer HC, Owen EC, Strycker LA, Smolkowski K, Muyskens JB, Kirkpatrick TK, Christie AD, Kuehl KS, Lantz BA, Shah SN, Mohler CG, Jewett BA. Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. JB JS Open Access. 2018 Jun 4;3(2):e0006. doi: 10.2106/JBJS.OA.18.00006. eCollection 2018 Jun 28.
- Background: PubMed 24135139Dreyer HC, Strycker LA, Senesac HA, Hocker AD, Smolkowski K, Shah SN, Jewett BA. Essential amino acid supplementation in patients following total knee arthroplasty. J Clin Invest. 2013 Nov;123(11):4654-66. doi: 10.1172/JCI70160. Epub 2013 Oct 25.
- Background: PubMed 30108034Kouw IWK, Groen BBL, Smeets JSJ, Kramer IF, van Kranenburg JMX, Nilwik R, Geurts JAP, Ten Broeke RHM, Poeze M, van Loon LJC, Verdijk LB. One Week of Hospitalization Following Elective Hip Surgery Induces Substantial Muscle Atrophy in Older Patients. J Am Med Dir Assoc. 2019 Jan;20(1):35-42. doi: 10.1016/j.jamda.2018.06.018. Epub 2018 Aug 11.
- Background: PubMed 33492623Dutaillis B, Maniar N, Opar DA, Hickey JT, Timmins RG. Lower Limb Muscle Size after Anterior Cruciate Ligament Injury: A Systematic Review and Meta-Analysis. Sports Med. 2021 Jun;51(6):1209-1226. doi: 10.1007/s40279-020-01419-0. Epub 2021 Jan 25.
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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.
Nancy R Rodriguez, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic and Osteo Arthritis Knee, run by University of Connecticut at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 16 Dec 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Protein Intake (time frame: Protein intake will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients). The study lists 2 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 NCT06734845, which also lists 9 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 16 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.