Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
Primary Purpose
Coxarthrosis, Muscle Weakness
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Capsulotomy with Repair
Capsuloectomy
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis focused on measuring Hip, Arthroplasty, Quadriceps strenght, Muscle Weakness, Knee, Flexion, Extension
Eligibility Criteria
Inclusion Criteria:
- All primary THA
Exclusion Criteria:
- Secondary THA
Sites / Locations
- Bezmialem Vakif University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capsulotomy with Repair
Capsuloectomy
Arm Description
Repair after capsulotomy in direct anterior hip arthroplasty
Capsuloectomy in direct anterior hip arthroplasty
Outcomes
Primary Outcome Measures
Muscle Weakness
Newton
Secondary Outcome Measures
Harris Hip Score
Score
Full Information
NCT ID
NCT04500093
First Posted
August 1, 2020
Last Updated
August 1, 2020
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04500093
Brief Title
Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
Official Title
Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2020 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
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
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.
Detailed Description
Published data assessing biomechanical performance after THR are sparse. The majority of studies assessing post-THR hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. These studies provide insight regarding the strength deficits of older adults after THR. However, the data are not consistent, making it difficult to assess the nature of the deficit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis, Muscle Weakness
Keywords
Hip, Arthroplasty, Quadriceps strenght, Muscle Weakness, Knee, Flexion, Extension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capsulotomy with Repair
Arm Type
Experimental
Arm Description
Repair after capsulotomy in direct anterior hip arthroplasty
Arm Title
Capsuloectomy
Arm Type
Active Comparator
Arm Description
Capsuloectomy in direct anterior hip arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Capsulotomy with Repair
Intervention Description
Capsulotomy with Repair
Intervention Type
Procedure
Intervention Name(s)
Capsuloectomy
Intervention Description
Capsuloectomy
Primary Outcome Measure Information:
Title
Muscle Weakness
Description
Newton
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Harris Hip Score
Description
Score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All primary THA
Exclusion Criteria:
Secondary THA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orkhan Aliyev, MD
Phone
+90 505 991 71 19
Email
orkhanaliyev@outlook.com.tr
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
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