Total hip replacement for osteoarthritis Surgery
Conditions
Interventions
Current intervention as of 02/03/2022:
The design of this study incorporates both quantitative and qualitative data collection and analyses, referred to as Workstream 1 (WS1) and Workstream 2 (WS2), r
a cost-utility analysis is also included in the PROMS. Workstream 2 is interviews with patients, surgeons and healthcare professionals, designed to obtain their thoughts on the randomized controlled t
Sponsors
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/07/2021: Recruitment rate measured by the: 1. Total number of patient participants randomised per month 2. Ratio of successful recruitment to eligible patients approached Timepoint(s): 7 months Previous primary outcome measure: Recruitment rate measured by the: 1. Total number of patient participants randomised per month 2. Ratio of successful recruitment to eligible patients approached Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/07/2021: 1. Adherence to the protocol will be measured by: 1.1. The number of minor (e.g. visit time-point violation) or major (e.g. violation of inclusion criteria) protocol deviations collected on a patient participant and site level between randomisation and the defined end of study 1.2. The percentage of patients in each arm that are accidentally unblinded measured between randomisation and the defined end of study 2. Trial withdrawal rate at 6 weeks and 3-6 months will be measured using the total number of patients randomised in the study. In addition, withdrawal rates will be presented by trial withdrawal reasons and withdrawal stage for both arms. 3. Patient participant population characteristics will be measured by collecting the following information: 3.1. Age – at randomisation 3.2. BMI – at randomisation 3.3. Proportion of missing data at the point of final analysis 3.4. Loss to follow up at the point of final analysis 4. Clinical and patient-reported data will be measured by collecting the following information: 4.1. Patient participant-reported outcomes including change in OHS, FJS, WPAI-SHP, SAPS score and quality of life measured using the EQ-5D- 5LTM at 6 weeks and 3-6 months 4.2. Revision rate, defined as the number of patient participants needing revision arthroplasty within 3-6 months of surgery 4.3. Infection rate, measured as the rate of re-operation for infection within 3-6 months of surgery 4.4. Length of stay, measured in hours between patient admission and initial discharge 4.5. Operation time, measured in minutes as the differences between the start and end of the operation 4.6. Incidence of treatment cross over measured as the surgically reported incidence of a patient receiving an intervention other than the one they were allocated through the randomisation system. 4.7. Incidence of intra-operative surgical complications, the proportion of patient participants experiencing greater than grade III | — |
Countries
England, United Kingdom
Outcome results
None listed