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Cup Revisions Through Anterior or Posterolateral Approach: an RCT

Primary Purpose

Loosening, Prosthesis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Anterior approach
Posterolateral approach
Sponsored by
Reinier Haga Orthopedisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loosening, Prosthesis focused on measuring Isolated cup revision, Hip revision surgery, Anterior approach, Posterolateral approach, Cup revision surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Reinier Haga Orthopedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anterior approach

Posterolateral approach

Arm Description

Cup revision surgery through the anterior approach

Cup revision surgery through the posterolateral approach

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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
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
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
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).
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).
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).
Patient reported outcome measure: Pain at rest
Measured using Numeric Rating Scale (NRS) for pain at rest
Patient reported outcome measure: Pain during movement
Measured using Numeric Rating Scale (NRS) for pain during movement
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.
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).
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).
Patient reported outcome measure: Satisfaction
Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?
Cup inclination
Categorized into ≤35°, 35° - 45° and ≥45°
Complications
Postoperative complications as recorded in the electronic patient file

Full Information

First Posted
August 12, 2022
Last Updated
September 8, 2022
Sponsor
Reinier Haga Orthopedisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT05508958
Brief Title
Cup Revisions Through Anterior or Posterolateral Approach: an RCT
Official Title
Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reinier Haga Orthopedisch Centrum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loosening, Prosthesis
Keywords
Isolated cup revision, Hip revision surgery, Anterior approach, Posterolateral approach, Cup revision surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Physiotherapist assessing functional tests will be blinded for treatment. Data analyst will be blinded for treatment.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anterior approach
Arm Type
Experimental
Arm Description
Cup revision surgery through the anterior approach
Arm Title
Posterolateral approach
Arm Type
Active Comparator
Arm Description
Cup revision surgery through the posterolateral approach
Intervention Type
Procedure
Intervention Name(s)
Anterior approach
Intervention Description
Anterior approach
Intervention Type
Procedure
Intervention Name(s)
Posterolateral approach
Intervention Description
Posterolateral approach
Primary Outcome Measure Information:
Title
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
Description
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).
Time Frame
6 weeks postoperatively
Title
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
Description
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).
Time Frame
6 weeks postoperatively
Title
Change from baseline Stair Climb Test (SCT) at 6 weeks
Description
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).
Time Frame
6 weeks postoperatively
Secondary Outcome Measure Information:
Title
Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year
Description
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year
Description
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year
Description
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year
Description
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).
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Title
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year
Description
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).
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Title
Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year
Description
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).
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Title
Patient reported outcome measure: Pain at rest
Description
Measured using Numeric Rating Scale (NRS) for pain at rest
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Patient reported outcome measure: Pain during movement
Description
Measured using Numeric Rating Scale (NRS) for pain during movement
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Patient reported outcome measure: Oxford Hip Score (OHS)
Description
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.
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Patient reported outcome measure: HOOS-PS
Description
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).
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Patient reported outcome measure: EQ-5D-5L
Description
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).
Time Frame
Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Title
Patient reported outcome measure: Satisfaction
Description
Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?
Time Frame
6 weeks, 3 months and 1 year postoperatively.
Title
Cup inclination
Description
Categorized into ≤35°, 35° - 45° and ≥45°
Time Frame
6 weeks postoperatively
Title
Complications
Description
Postoperative complications as recorded in the electronic patient file
Time Frame
30 days postoperatively and 90 days postoperatively
Other Pre-specified Outcome Measures:
Title
Lowgrade infection
Description
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.
Time Frame
6 weeks, 3 months and 1 year postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Rutgers, MD
Organizational Affiliation
Reinier Haga Orthopedisch Centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reinier Haga Orthopedic Center
City
Zoetermeer
ZIP/Postal Code
2725 NA
Country
Netherlands

12. IPD Sharing Statement

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Cup Revisions Through Anterior or Posterolateral Approach: an RCT

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