Clinical study comparing cementless Polar stem and the cementless Corail stem in total hip replacement

Not Applicable

Completed

• Conditions: Hip osteoarthritis, total hip replacement; Musculoskeletal Diseases; Coxarthrosis

• Registration Number: ISRCTN81577353
• Lead Sponsor: Joint UCL / UCLH / Royal Free Biomedical Research Unit (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Study Completion: 2020-07-01
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. The surgeon and the patient must agree that total hip replacement (THR) is necessary
2. The patient must be fit for THR in the opinion of the surgeon and the interdisciplinary team
3. The indication for THR must be primary osteoarthritis, avascular necrosis, femoral neck fracture, or hip dysplasia
4. Patients requiring primary arthroplasty
5. Patients must be aged between 50 -? 75 years at the time of surgery
6. Both male and female
7. The patient must be capable of giving informed consent and express a willingness to comply with the post-operative review program
8. The patient must be a permanent resident in an area accessible to the study site

Exclusion Criteria

1. Post-traumatic OA (proximal femur fracture)
2. Post-infection in respective joint
3. Prior osteotomy of the affected hip
4. Patients under treatment for osteoporosis (with bisphosphonate)
5. OA patients diagnosed Charnley Classification
6. Patients requiring cortisone medication
7. Patients whose body mass index is higher than 35
8. Patients already participating in the RSA hip study.
9. The individual is unable or unwilling to sign the patient informed consent specific to this study
10. Previous THR on contra-lateral side
11. Patients requiring revision arthroplasty

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of migration of the cementless Polar stem (Smith & Nephew Orthopaedics) with a well established cementless collarless and collared comparison stem (Corail, DePuy Orthopedics) in THR, by using RSA

Secondary Outcome Measures

Name	Time	Method
<br> 1. Comparison of migration of the cementless R3 cup (Smith & Nephew Orthopaedics) with a well established cementless comparison (Pinnacle, DePuy Orthopedics) by using RSA<br> 2. Documenting the performance of the Polar and Corail implants in the clinical setting over two years post-operatively, using information on infection and complication rates and specific Health Related Quality of Life (HRQoL) outcome/satisfaction scores to see whether there is any difference in performance<br>