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

• Sponsor: ZOL (Other)
• Overall Status: Completed
• CT.gov ID: NCT02970253
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arms: 2
• Actual Duration (Months): 26
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coxarthritis	Procedure: Capsular resection; Procedure: Capsular retention	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Nov 11, 2018
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Capsular resection Capsular resection	Procedure: Capsular resection; Capsular resection
Active Comparator: Capsular retention Capsular retention	Procedure: Capsular retention; Capsular retention

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• primary THA

Exclusion Criteria:

• neurologic disease

• painful contralateral THA

• severe back or knee pain

• rheumatology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ZOL	Genk	Limburg	Belgium	3600

Sponsors and Collaborators

• ZOL

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Vanbiervliet, Resident Orthopedic Surgery, ZOL
• ClinicalTrials.gov Identifier: NCT02970253
• Other Study ID Numbers: 16/076U
• First Posted: Nov 21, 2016
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 11, 2020