Cup Revisions Through Anterior or Posterolateral Approach: an RCT

NCT ID: NCT05508958

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anterior approach

Cup revision surgery through the anterior approach

Group Type: EXPERIMENTAL

Anterior approach

Intervention Type: PROCEDURE

Anterior approach

Posterolateral approach

Cup revision surgery through the posterolateral approach

Group Type: ACTIVE_COMPARATOR

Posterolateral approach

Intervention Type: PROCEDURE

Posterolateral approach

Interventions

Anterior approach

Anterior approach

Intervention Type: PROCEDURE

Posterolateral approach

Posterolateral approach

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reinier Haga Orthopedisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Rutgers, MD

Role: PRINCIPAL_INVESTIGATOR

Reinier Haga Orthopedisch Centrum

Locations

Reinier Haga Orthopedic Center

Zoetermeer, , Netherlands

Countries

Netherlands

Other Identifiers

OC-2020-018

Identifier Type: -

Identifier Source: org_study_id