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OpenTrials
Completed

NCT Number: NCT02970253

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

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.

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Key information

Conditions

Coxarthritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ZOL

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary THA

Exclusion criteria

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

Treatment and study plan

Capsular resection

Procedure

Capsular resection

Capsular retention

Procedure

Capsular retention

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

ZOL

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 21, 2016
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.