Clinical trial NCT05508958: Cup Revisions Through Anterior or Posterolateral Approach: an RCT
Official title: Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Loosening, Prosthesis
Keywords: Isolated cup revision
Hip revision surgery
Anterior approach
Posterolateral approach
Cup revision surgery
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* 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

Primary outcomes:
measure: Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
timeFrame: 6 weeks postoperatively
measure: Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
timeFrame: 6 weeks postoperatively
measure: Change from baseline Stair Climb Test (SCT) at 6 weeks
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
measure: Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
measure: Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
measure: Patient reported outcome measure: Pain at rest
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Patient reported outcome measure: Pain during movement
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Patient reported outcome measure: Oxford Hip Score (OHS)
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Patient reported outcome measure: HOOS-PS
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Patient reported outcome measure: EQ-5D-5L
timeFrame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
measure: Patient reported outcome measure: Satisfaction
timeFrame: 6 weeks, 3 months and 1 year postoperatively.
measure: Cup inclination
timeFrame: 6 weeks postoperatively
measure: Complications
timeFrame: 30 days postoperatively and 90 days postoperatively
Other outcomes:
measure: Lowgrade infection
timeFrame: 6 weeks, 3 months and 1 year postoperatively.
Locations:
city: Zoetermeer
country: Netherlands
facility: Reinier Haga Orthopedic Center
Study officials:
affiliation: Reinier Haga Orthopedisch Centrum
name: M. Rutgers, MD
role: PRINCIPAL_INVESTIGATOR
References: