Anterior Capsulectomy vs. Repair in Direct Anterior THA

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01621932
First received: June 14, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Total Hip Arthroplasty
Procedure: Direct anterior approach with capsulectomy
Procedure: Direct anterior approach without capsulectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterior Capsulectomy vs. Repair in Direct Anterior THA

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Hip flexion [ Time Frame: postoperative 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analog scale-pain [ Time Frame: 4 months and 12 months post operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621932

Contacts
Contact: Susan M Odum, MEd 704.323.2265 susan.odum@orthocarolina.com

Locations
United States, North Carolina
OrthoCarolina, P.A. Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, MEd    704-323-2265    susan.odum@orthocarolina.com   
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: John Masonis, MD OrthoCarolina, P.A.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01621932     History of Changes
Other Study ID Numbers: 101105A
Study First Received: June 14, 2012
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 10, 2014