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

A prospective, randomised, single centre clinical study comparing cementless Polar stem and the cementless Corail stem in total hip replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81577353
Enrollment
75
Registered
2012-03-21
Start date
2015-11-02
Completion date
Unknown
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip osteoarthritis, total hip replacement Musculoskeletal Diseases Coxarthrosis

Interventions

The 75 patients recruited to the study will be randomly allocated to one of 3 groups: 1. Polar stem + R3 cup 2. Corail collarless + Pinnacle cup 3. Cora
they will not be aware of the prosthesis they have received until the end of the study. Although it is possible to randomise and blind the prosthesis to the patient and the Researcher gathering outcom

Sponsors

Joint UCL / UCLH / Royal Free Biomedical Research Unit (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Comparison of migration of the cementless R3 cup (Smith & Nephew Orthopaedics) with a well established cementless comparison (Pinnacle, DePuy Orthopedics) by using RSA 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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026