Feasibility study for a comparative trial of hybrid or cemented implants for total hip replacement. Hip arthroplasty with Hybrid Or cemented implants: Patient-reported outcomes (HipHOP)

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 89 人开始时间: 2021年2月19日最近更新: 2022年5月23日

试验速览

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•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

•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

发起方

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust