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Clinical Trials/NCT02970253
NCT02970253CompletedPhase 1

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

ZOL1 site in 1 country190 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
ZOL
Enrollment
190
Locations
1
Primary Endpoint
Clinical data will be measured with scoring list HHS (Harris Hip Score).

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •primary THA

Exclusion Criteria

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

Arms & Interventions

Capsular resection

Active Comparator

Capsular resection

Intervention: Capsular resection (Procedure)

Capsular retention

Active Comparator

Capsular retention

Intervention: Capsular retention (Procedure)

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
ZOL
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jens Vanbiervliet

Resident Orthopedic Surgery

ZOL

Study Sites (1)

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