Difference in Return to Sports Activity After Hip Arthroplasty by THR or Resurfacing

NCT06410079 | Not Yet Recruiting

• 1 other identifier: 2023 A02666
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the return to activity in younger patients under 50 years old after undergoing either total hip replacement (THR) or hip resurfacing, as performed in everyday practice. This research will be observational, meaning patients will not be randomly assigned to different treatment groups. To objectively assess participents; return to everyday, professional, and sports activities, validated questionnaires will be sent to participents in addition to routine clinical practice. The study will be prospective and comparative based on the type of prostheses used. In order to capture the current practices of surgeons performing THR in participents under 50 years old in France, the study will be conducted at multiple centers across the country. Since hip resurfacing is performed only in certain centers, approximately half of the participating centers are experienced in this technique. Participents typically resume activity between 3 and 6 months after THR. One year of post-operative follow-up allows for an accurate assessment of participents; recovery, unaffected by the surgery. Participents ; physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty.

Conditions

Hip Arthrosis; Femur Head Necrosis

Outcome Measures

Primary Outcomes (1)

• UCLA hip score

  The UCLA Hip Score is a validated measurement tool used to assess the level of physical activity in patients undergoing hip arthroplasty. It consists of a single-item scale ranging from 10 to 1. A score of 10 indicates regular participation in impact sports, while a score of 1 indicates complete inactivity and dependency on others. This score is utilized to evaluate the patient's functional outcome and activity level following hip surgery.

  Day 0, and 3 ,6,12 mounths

Secondary Outcomes (10)

• Subjective Hip Value (SHV) Score

  Days 14 and 3,6, 12 mounths

• The Forgotten Joint Score (FJS)

  Day 0, and 3 ,6,12 mounths

• Oxford Hip Score (OHS)

  Day 0, and 3 ,6,12 mounths

• The DEVANE Score

  Day 0, 12 mounths

• Age

  Day 0

Study Arms (2)

resurfacing

involves removing damaged cartilage and bone from the hip joint, half of the femoral head is cut, the neck and the other half are preserved, the acetabulum is covered by a metal cup

Procedure: total hip replacement

total hip prosthesis

dual mobility total hip prosthesis in polyethylene, ceramic hip prosthesis, total hip prosthesis in ceramic or metal and polyethylene

Procedure: total hip replacement

Interventions

total hip replacement PROCEDURE

Replacement of the hip joint with a total prosthesis, a femoral stem, an acetabular cup, a joint head, in metal, ceramic, dual mobility or polyethylene

resurfacing; total hip prosthesis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited by surgeons during orthopedic surgery consultations at each of the participating centers in the study. These consultations will take place between 3 and 1 month before the intervention. The purpose of the research will be explained to all patients who meet the eligibility criteria by the surgeon and an information sheet will be given to them. The physician will obtain the patients consent to participate in the research and their non-opposition to the collection and use of their data at least 14 days before the intervention, allowing sufficient time for the participant to reflect.

You may qualify if:

• Participant is male or female, aged 50 or under
• Participant is indicated for a primary THA or resurfacing procedure
• Participant agrees to complete and receive questionnaires by email
• Participant has been informed and has not objected to the collection and use of their data

You may not qualify if:

• Participant is aged under 18 or over 50 years
• Participant has had a previous THA or resurfacing procedure
• Participant is scheduled for a THA on the other hip within the year
• Participant has severe physical and/or psychological health problems that, in the investigators opinion, may affect the participant\'s compliance with the study
• Participant is participating in another research study
• Participant is a protected person: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Participant is pregnant, breastfeeding or giving birth
• Participant is hospitalized without consent

Sponsors & Collaborators

• Société Française de chirurgie de la Hanche et du Genou: lead
• Elsan: collaborator

Study Sites (1)

Santé Atlantique

Saint-Herblain, Nantes, 44800, France

Location

Related Links

• official page of Société Française de chirurgie de la Hanche et du Genou

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Ronald Isida, MD

  SFHG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Marie PHILIPPEAU, MD

CONTACT

024-012-7701; jmphilippeau@hotmail.com

Nacim MIRI, CTM

CONTACT

076-447-5298; docteurmiri@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2024
• Primary Completion: March 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)