Cup Revisions Through Anterior or Posterolateral Approach: an RCT

NCT05508958 | Enrolling By Invitation

• 1 other identifier: OC-2020-018
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Loosening, Prosthesis

Keywords

Isolated cup revision; Hip revision surgery; Anterior approach; Posterolateral approach; Cup revision surgery

Outcome Measures

Primary Outcomes (3)

• Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks

  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).

  6 weeks postoperatively

• Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks

  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).

  6 weeks postoperatively

• Change from baseline Stair Climb Test (SCT) at 6 weeks

  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).

  6 weeks postoperatively

Secondary Outcomes (14)

• 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.

• 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 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

Other Outcomes (1)

• Lowgrade infection

  6 weeks, 3 months and 1 year postoperatively.

Study Arms (2)

Anterior approach

EXPERIMENTAL

Cup revision surgery through the anterior approach

Procedure: Anterior approach

Posterolateral approach

ACTIVE COMPARATOR

Cup revision surgery through the posterolateral approach

Procedure: Posterolateral approach

Interventions

Anterior approach PROCEDURE

Anterior approach

Anterior approach

Posterolateral approach PROCEDURE

Posterolateral approach

Posterolateral approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• On waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach
• A good command of the Dutch language

You may not qualify if:

• 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

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead

Study Sites (1)

Reinier Haga Orthopedic Center

Zoetermeer, 2725 NA, Netherlands

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M. Rutgers, MD

  Reinier Haga Orthopedisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physiotherapist assessing functional tests will be blinded for treatment. Data analyst will be blinded for treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: September 8, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

NL (1)