Feasibility study of hybrid or cemented implants for total hip replacement

Not Applicable

Completed

• Conditions: Total hip replacement for osteoarthritis; Surgery

• Registration Number: ISRCTN11097021
• Lead Sponsor: Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-19
• Study Completion: 2022-04-30
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Workstream 1:
1. Age 18 years and above
2. Undergoing a primary total hip arthroplasty with either a fully cemented or hybrid implant*
3. Able to give informed consent prior to randomisation
4. Able to communicate in both written and spoken English
* All implants and bone cements that are used must be CE marked and used in accordance with their intended use. There is no limitation as to the manufacturer of prostheses used and surgeons will continue to use the implants that they are familiar with. Furthermore, surgeons will be free to use whichever head/socket material and diameter they feel appropriate. The surgical approach, anaesthetic type, rehabilitation after surgery and other concomitant factors will be as per the surgeons’ normal care. These factors will be recorded

Workstream 2:
Patient sample:
5. Have been approached to take part in Workstream 1
Surgeon sample:
6. Consultant orthopaedic surgeon at a Workstream 1 site or a potential site for a future full trial
Research nurse sample - Updated 27/07/2021: Healthcare professional sample:
7. Involved in recruiting to Workstream 1 and/or collecting patient self-reported data

Exclusion Criteria

Workstream 1:
1. Previous surgery to the hip joint
2. All procedures with an indication other than osteoarthritis
3. Patient requiring complex total hip arthroplasty surgery, specifically augmentation of the acetabulum (eg structural bone graft or metal augment) and/or shortening/de-rotational osteotomy of the femur at the time of surgery
4. Patients requiring bilateral simultaneous total hip arthroplasty
5. Vision impairment that precludes the completion of PROMS questionnaires

Workstream 2:
All participants:
6. Hearing impairment that precludes communication by standard telephone

Study & Design

• Study Type: Interventional
• Study Design: Not specified