Impact of Pre-operative Sarcopenia on Functional Recovery After Hip Arthroplasty in Older Adults

NCT07429955 | Not Yet Recruiting

• 2 other identifiers: RECHMPL23_03482024-A02779-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia in Elderly; Osteoarthritis (OA); Hip Fracture Surgeries

Keywords

Sarcopenia in Elderly; Osteoarthritis (OA); Hip Fracture Surgeries; Functional Recovery; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline and 3 months

• Change from Baseline in the Barthel Index at 6 months post-operative

  Baseline and 6 months

• Measurement of hand-grip strength via dynamometry

  Assessment of preoperative sarcopenia severity

  Baseline

• Measurement of appendicular lean mass by DXA

  Assessment of preoperative sarcopenia severity

  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).

  Prior to surgery or within 7 days postoperatively

Secondary Outcomes (16)

• Number of myoblastic progenitors at proliferation onset

  Intraoperative

• Mean myotube surface area at differentiation end

  Intraoperative

• Proportion of senescent MSCs

  Intraoperative

• Number of chondrocytes obtained from MSCs at differentiation end

  Intraoperative

• Number of adipocytes obtained from MSCs at differentiation end

  Intraoperative

Study Arms (1)

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

Interventions

Total hip replacement PROCEDURE

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.

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

Blood sampling BIOLOGICAL

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.

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

Muscle biopsies BIOLOGICAL

Performed during hip arthroplasty

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

Collection of joint samples derived from surgical waste BIOLOGICAL

Performed during hip arthroplasty

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

DXA RADIATION

Within 15 days following the surgical procedure, during hospitalization/rehabilitation

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

MRI OTHER

Within 15 days following the surgical procedure, during hospitalization/rehabilitation

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

Handgrip strength test OTHER

Measurement of handgrip strength using a hand dynamometer

Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgery

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Elderly subjects undergoing surgical hip replacement for fracture of the upper end of the femur or severe hip osteoarthritis.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34090, France

Location

Related Publications (20)

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  PMID: 37675071 BACKGROUND

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  PMID: 12502201 BACKGROUND

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  PMID: 22473333 BACKGROUND

• Brzeszczynska 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.

  PMID: 29214748 BACKGROUND

• Fox 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.

  PMID: 10663356 BACKGROUND

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  PMID: 17885314 BACKGROUND

• Maden-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.

  PMID: 23989253 BACKGROUND

• Fuchs 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.

  PMID: 36967049 BACKGROUND

• Vergara 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.

  PMID: 25425462 BACKGROUND

• Gielen 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.

  PMID: 37348597 BACKGROUND

• Di 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.

  PMID: 20207030 BACKGROUND

• Haute Autorité de Santé. Prothèses de hanche. Saint-Denis La Plaine: HAS; 2013.

  BACKGROUND

• 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.

  PMID: 30312372 BACKGROUND

• Clynes 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.

  PMID: 33276373 BACKGROUND

• Candel-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.

  PMID: 19080883 BACKGROUND

• Maravic M, Taupin P, Landais P, Roux C. Change in hip fracture incidence over the last 6 years in France. Osteoporos Int. 2011 Mar;22(3):797-801. doi: 10.1007/s00198-010-1255-9. Epub 2010 Jun 2.

  PMID: 20517692 BACKGROUND

• Desmond Curran, et al. Épidémiologie des fractures liées à l'ostéoporose en France : revue de la littérature, Revue du Rhumatisme, Volume 77, Issue 6, 2010, Pages 579-585,ISSN 1169-8330

  BACKGROUND

• Putman S, et al. Épidémiologie des prothèses de hanche en France : analyse de la base nationale du PMSI de 2008 à 2014, Revue de Chirurgie Orthopédique et Traumatologique,Volume 103, Issue 7, Supplement, 2017, Page S90, ISSN 1877-0517

  BACKGROUND

• Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014 Jul;10(7):437-41. doi: 10.1038/nrrheum.2014.44. Epub 2014 Mar 25.

  PMID: 24662640 BACKGROUND

• Kloppenburg M, Berenbaum F. Osteoarthritis year in review 2019: epidemiology and therapy. Osteoarthritis Cartilage. 2020 Mar;28(3):242-248. doi: 10.1016/j.joca.2020.01.002. Epub 2020 Jan 13.

  PMID: 31945457 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Investigative Techniques

Central Study Contacts

Jean Baptiste ROBIAUD, Assistant head physician

CONTACT

+33629184092; jbrobiaud@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: February 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)