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

Coxarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970253
• Other study ID #: 16/076U
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: ZOL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 31, 2019
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary THA

Exclusion Criteria:

• neurologic disease

• painful contralateral THA

• severe back or knee pain

• rheumatology

Related Conditions & MeSH terms

• Coxarthritis

Intervention

Procedure:
• Capsular resection
Capsular resection
• Capsular retention
Capsular retention

Locations

Country	Name	City	State
Belgium	ZOL	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
ZOL

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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