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Anterior Capsulectomy vs. Repair in Direct Anterior THA

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ClinicalTrials.gov Identifier: NCT01621932
Recruitment Status : Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief Summary:

Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.

The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.


Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Procedure: Direct anterior approach with capsulectomy Procedure: Direct anterior approach without capsulectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterior Capsulectomy vs. Repair in Direct Anterior THA
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Surgical approach 1
Direct anterior surgical approach with capsulectomy
Procedure: Direct anterior approach with capsulectomy
Direct anterior approach with capsulectomy

Active Comparator: Surgical approach 2
Direct anterior approach without capsulectomy
Procedure: Direct anterior approach without capsulectomy
Direct anterior approach without capsulectomy




Primary Outcome Measures :
  1. Hip flexion [ Time Frame: postoperative 4 months ]

Secondary Outcome Measures :
  1. Visual analog scale-pain [ Time Frame: 4 months and 12 months post operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older

Exclusion Criteria:

  • Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621932


Locations
United States, North Carolina
OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: John Masonis, MD OrthoCarolina, P.A.

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01621932     History of Changes
Other Study ID Numbers: 101105A
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: September 2017

Keywords provided by OrthoCarolina Research Institute, Inc.:
Anterior approach