Cup Revisions Through Anterior or Posterolateral Approach: an RCT

Loosening, Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05508958
• Other study ID #: OC-2020-018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: February 2026

Study information

• Verified date: September 2022
• Source: Reinier Haga Orthopedisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Loosening, Prosthesis
• Prosthesis Failure

Intervention

Procedure:
• Anterior approach
Anterior approach
• Posterolateral approach
Posterolateral approach

Locations

Country	Name	City	State
Netherlands	Reinier Haga Orthopedic Center	Zoetermeer

Sponsors (1)

Lead Sponsor	Collaborator
Reinier Haga Orthopedisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Cup inclination	Categorized into =35°, 35° - 45° and =45°	6 weeks postoperatively
Secondary	Complications	Postoperative complications as recorded in the electronic patient file	30 days postoperatively and 90 days postoperatively