Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Loosening, Prosthesis
- Sponsor
- Reinier Haga Orthopedisch Centrum
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
Brief Summary
With increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. While the anterior approach for primary total hip arthroplasty has demonstrated to result in a faster short-term recovery than the traditional lateral and posterior approach, this effect has not yet been investigated in revision surgery. Accelerating functional outcome may increase patient satisfaction and reduce healthcare costs.
The primary objective is to assess whether isolated cup revision surgery through the anterior approach results in increased functional status and higher patient satisfaction than through the posterolateral approach.
This is a prospective Randomized Controlled Trial (RCT) in which 68 patients will be included (34 per group). Patients will be evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.
The main endpoints are functional recovery as measured with the 30-sec Chair Stand Test (30s-CST), 40m Fast Paced Walking Test (40m FPWT) and the Stair Climb Test (SCT).
Secondary endpoints are Modified Borg scale outcomes after the functional tests, Numeric Rating Scale (NRS) for pain (rest/movement), Oxford Hip Score (OHS), HOOS-PS, EQ-5D-5L, satisfaction, cup inclination and complications at 30 days and 90 days postoperatively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •On waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach
- •A good command of the Dutch language
Exclusion Criteria
- •Revision for confirmed or suspected infection
- •Not suitable for both approaches under study, as judged by orthopaedic surgeon
- •Unable to fully understand study information and to accurately/reliably complete the questionnaires, as judged by researcher and/or orthopaedic surgeon
- •Unable to accurately follow instructions for study procedures / measurements, as judged by researcher and/or orthopaedic surgeon
- •Unwilling to sign informed consent form
Outcomes
Primary Outcomes
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
Time Frame: 6 weeks postoperatively
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
Time Frame: 6 weeks postoperatively
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Change from baseline Stair Climb Test (SCT) at 6 weeks
Time Frame: 6 weeks postoperatively
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Secondary Outcomes
- Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively)
- Patient reported outcome measure: Pain at rest(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Patient reported outcome measure: Pain during movement(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Cup inclination(6 weeks postoperatively)
- Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively)
- Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively)
- Patient reported outcome measure: Oxford Hip Score (OHS)(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Patient reported outcome measure: HOOS-PS(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Patient reported outcome measure: EQ-5D-5L(Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.)
- Patient reported outcome measure: Satisfaction(6 weeks, 3 months and 1 year postoperatively.)
- Complications(30 days postoperatively and 90 days postoperatively)