Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
1 other identifier
interventional
190
1 country
1
Brief Summary
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention. Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2017
Typical duration for phase_1
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
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 11, 2020
February 1, 2020
1 year
November 3, 2016
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Clinical data will be measured with scoring list HHS (Harris Hip Score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).
One year
Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
One year
Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).
One year
Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
One year
Study Arms (2)
Capsular resection
ACTIVE COMPARATORCapsular resection
Capsular retention
ACTIVE COMPARATORCapsular retention
Interventions
Eligibility Criteria
You may qualify if:
- primary THA
You may not qualify if:
- neurologic disease
- painful contralateral THA
- severe back or knee pain
- rheumatology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZOLlead
Study Sites (1)
ZOL
Genk, Limburg, 3600, Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Orthopedic Surgery
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 21, 2016
Study Start
November 1, 2017
Primary Completion
November 11, 2018
Study Completion
December 31, 2019
Last Updated
February 11, 2020
Record last verified: 2020-02