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

Phase 1

Completed

• Conditions: Coxarthritis
• Interventions: Procedure: Capsular retention; Procedure: Capsular resection

• Registration Number: NCT02970253
• Lead Sponsor: ZOL

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Study Start: 2017-11-01
• Primary Completion: 2018-11-11
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• primary THA

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsular retention	Capsular retention	Capsular retention
Capsular resection	Capsular resection	Capsular resection

Primary Outcome Measures

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

Trial Locations

Locations (1)

ZOL; 🇧🇪 Genk, Limburg, Belgium