Cup Revisions Through Anterior or Posterolateral Approach: an RCT

Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Loosening, Prosthesis
• Intervention / Treatment: Procedure: Anterior approach; Procedure: Posterolateral approach

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zoetermeer, Netherlands, 2725 NA
    • Reinier Haga Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anterior approach; Cup revision surgery through the anterior approach	Procedure: Anterior approach; Anterior approach
ACTIVE_COMPARATOR: Posterolateral approach; Cup revision surgery through the posterolateral approach	Procedure: Posterolateral approach; Posterolateral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year	We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks	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	We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks	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	We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks	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	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).	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	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).	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	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).	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Patient reported outcome measure: Pain at rest	Measured using Numeric Rating Scale (NRS) for pain at rest	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Pain during movement	Measured using Numeric Rating Scale (NRS) for pain during movement	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Oxford Hip Score (OHS)	The Oxford Hip Score (OHS) is a hip specific questionnaire, consisting of 12 items concerning pain and daily functions. In the original scoring, each question is scored on a 5-point Likert scale, ranging from 1 (no pain/easy to do) to 5 (unbearable/impossible to do). The original total score ranges from 12 (best) to 60 (worst) points. It has been developed for total hip surgery. In the revised scoring, each question is scored from 0 (worst) to 4 (best), ranging the total score from 0 (worst) to 48 (best) (20). The revised scoring will be used in this study.	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: HOOS-PS	The HOOS-PS is a short measure of physical function for hip osteoarthritis (OA), derived from the original, longer, Hip disability and Osteoarthritis Outcome Score (HOOS). The raw scoring ranges from 0 (none) to 4 (extreme) per question, for a total raw score range of 0 to 20 (lower is less difficulty). The person interval level score ranges, which can be calculated from the total raw score using a nomogram, ranges from 0 (no difficulty) to 100 (extreme difficulty).	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: EQ-5D-5L	EuroQol-5D (EQ-5D) is a general health-related quality of life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality adjusted life years (QALY).	Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Satisfaction	Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?	6 weeks, 3 months and 1 year postoperatively.
Cup inclination	Categorized into ≤35°, 35° - 45° and ≥45°	6 weeks postoperatively
Complications	Postoperative complications as recorded in the electronic patient file	30 days postoperatively and 90 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowgrade infection	To investigate selection bias caused by loss to follow up, the investigators will also record whether a lowgrade infection was determined during or after revision surgery.	6 weeks, 3 months and 1 year postoperatively.

Collaborators and Investigators

• Sponsor: Reinier Haga Orthopedisch Centrum
• Investigators: Principal Investigator: M. Rutgers, MD, Reinier Haga Orthopedisch Centrum

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2022
• Primary Completion (ANTICIPATED): February 1, 2026
• Study Completion (ANTICIPATED): February 1, 2026

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (ACTUAL): August 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Hip revision surgery; Anterior approach; Isolated cup revision; Posterolateral approach; Cup revision surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: OC-2020-018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No