Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
1 other identifier
interventional
40
1 country
1
Brief Summary
Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. However, there is still a gap between the clinical scores in objective surveys and patient satisfaction. Direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. In this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2020
CompletedStudy Start
First participant enrolled
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedAugust 5, 2020
August 1, 2020
2.1 years
August 1, 2020
August 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle Weakness
Newton
1 year
Secondary Outcomes (1)
Harris Hip Score
1 year
Study Arms (2)
Capsulotomy with Repair
EXPERIMENTALRepair after capsulotomy in direct anterior hip arthroplasty
Capsuloectomy
ACTIVE COMPARATORCapsuloectomy in direct anterior hip arthroplasty
Interventions
Eligibility Criteria
You may qualify if:
- All primary THA
You may not qualify if:
- Secondary THA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Resident Doctor in Orthopaedic Surgery
Study Record Dates
First Submitted
August 1, 2020
First Posted
August 5, 2020
Study Start
August 2, 2020
Primary Completion
August 30, 2022
Study Completion
November 30, 2022
Last Updated
August 5, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP