Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-31 @ 6:05 PM
Study NCT ID:
NCT05508958
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-09-13
First Post:
2022-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cup Revisions Through Anterior or Posterolateral Approach: an RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Physiotherapist assessing functional tests will be blinded for treatment. Data analyst will be blinded for treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lowgrade infection', 'timeFrame': '6 weeks, 3 months and 1 year postoperatively.', '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.'}], 'primaryOutcomes': [{'measure': 'Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks', 'timeFrame': '6 weeks postoperatively', '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).'}, {'measure': 'Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks', 'timeFrame': '6 weeks postoperatively', '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).'}, {'measure': 'Change from baseline Stair Climb Test (SCT) at 6 weeks', 'timeFrame': '6 weeks postoperatively', '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).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', 'description': "We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks"}, {'measure': 'Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', 'description': "We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks"}, {'measure': 'Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', 'description': "We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks"}, {'measure': 'Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively', '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).'}, {'measure': 'Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively', '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).'}, {'measure': 'Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively', '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).'}, {'measure': 'Patient reported outcome measure: Pain at rest', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', 'description': 'Measured using Numeric Rating Scale (NRS) for pain at rest'}, {'measure': 'Patient reported outcome measure: Pain during movement', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', 'description': 'Measured using Numeric Rating Scale (NRS) for pain during movement'}, {'measure': 'Patient reported outcome measure: Oxford Hip Score (OHS)', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', '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.'}, {'measure': 'Patient reported outcome measure: HOOS-PS', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', '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).'}, {'measure': 'Patient reported outcome measure: EQ-5D-5L', 'timeFrame': 'Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.', '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).'}, {'measure': 'Patient reported outcome measure: Satisfaction', 'timeFrame': '6 weeks, 3 months and 1 year postoperatively.', 'description': 'Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?'}, {'measure': 'Cup inclination', 'timeFrame': '6 weeks postoperatively', 'description': 'Categorized into ≤35°, 35° - 45° and ≥45°'}, {'measure': 'Complications', 'timeFrame': '30 days postoperatively and 90 days postoperatively', 'description': 'Postoperative complications as recorded in the electronic patient file'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isolated cup revision', 'Hip revision surgery', 'Anterior approach', 'Posterolateral approach', 'Cup revision surgery'], 'conditions': ['Loosening, Prosthesis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThis 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.\n\nThe 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).\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* On waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach\n* A good command of the Dutch language\n\nExclusion Criteria:\n\n* Revision for confirmed or suspected infection\n* Not suitable for both approaches under study, as judged by orthopaedic surgeon\n* Unable to fully understand study information and to accurately/reliably complete the questionnaires, as judged by researcher and/or orthopaedic surgeon\n* Unable to accurately follow instructions for study procedures / measurements, as judged by researcher and/or orthopaedic surgeon\n* Unwilling to sign informed consent form'}, 'identificationModule': {'nctId': 'NCT05508958', 'briefTitle': 'Cup Revisions Through Anterior or Posterolateral Approach: an RCT', 'organization': {'class': 'OTHER', 'fullName': 'Reinier Haga Orthopedisch Centrum'}, 'officialTitle': 'Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?', 'orgStudyIdInfo': {'id': 'OC-2020-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anterior approach', 'description': 'Cup revision surgery through the anterior approach', 'interventionNames': ['Procedure: Anterior approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Posterolateral approach', 'description': 'Cup revision surgery through the posterolateral approach', 'interventionNames': ['Procedure: Posterolateral approach']}], 'interventions': [{'name': 'Anterior approach', 'type': 'PROCEDURE', 'description': 'Anterior approach', 'armGroupLabels': ['Anterior approach']}, {'name': 'Posterolateral approach', 'type': 'PROCEDURE', 'description': 'Posterolateral approach', 'armGroupLabels': ['Posterolateral approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2725 NA', 'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Reinier Haga Orthopedic Center', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'M. Rutgers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reinier Haga Orthopedisch Centrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reinier Haga Orthopedisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}