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Clinical Trials/NCT02970253
NCT02970253
Completed
Phase 1

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

ZOL1 site in 1 country190 target enrollmentNovember 1, 2017
ConditionsCoxarthritis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Coxarthritis
Sponsor
ZOL
Enrollment
190
Locations
1
Primary Endpoint
Clinical data will be measured with scoring list HHS (Harris Hip Score).
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ZOL
Responsible Party
Principal Investigator
Principal Investigator

Jens Vanbiervliet

Resident Orthopedic Surgery

ZOL

Eligibility Criteria

Inclusion Criteria

  • primary THA

Exclusion Criteria

  • neurologic disease
  • painful contralateral THA
  • severe back or knee pain
  • rheumatology

Outcomes

Primary Outcomes

Clinical data will be measured with scoring list HHS (Harris Hip Score).

Time Frame: One year

Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).

Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).

Time Frame: One year

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).

Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).

Time Frame: One year

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).

Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).

Time Frame: One year

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).

Study Sites (1)

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