Health TrialsbyHealthPanel

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

ConditionsSarcopenia in ElderlyOsteoarthritis (OA)Hip Fracture Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Total hip replacement

    Procedure/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 sampling

    Biological/Vaccine

    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 biopsies

    Biological/Vaccine

    Performed during hip arthroplasty

  • Collection of joint samples derived from surgical waste

    Biological/Vaccine

    Performed during hip arthroplasty

  • DXA

    Radiation

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

  • MRI

    Other intervention

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

  • Handgrip strength test

    Other intervention

    Measurement of handgrip strength using a hand dynamometer

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Elderly subjects with a femoral neck fracture or severe hip osteoarthritis requiring surgeryExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 3 months
2

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

Time frame
Baseline and 6 months
3

Measurement of hand-grip strength via dynamometry

Assessment of preoperative sarcopenia severity

Time frame
Baseline
4

Measurement of appendicular lean mass by DXA

Assessment of preoperative sarcopenia severity

Time frame
Prior to surgery or within 7 days postoperatively

Secondary outcomes

1

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).

Time frame
Intraoperative
2

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).

Time frame
Intraoperative
3

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).

Time frame
Intraoperative
4

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.

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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