Cup Revisions Through Anterior or Posterolateral Approach: an RCT

Reinier Haga Orthopedisch Centrum

Status

Invitation-only

Conditions

Loosening, Prosthesis

Treatments

Procedure: Anterior approach

Procedure: Posterolateral approach

Study type

Interventional

Funder types

Other

Identifiers

NCT05508958

OC-2020-018

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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