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

June 14, 2012
June 26, 2014
March 2012
March 2016   (final data collection date for primary outcome measure)
Hip flexion [ Time Frame: postoperative 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01621932 on ClinicalTrials.gov Archive Site
Visual analog scale-pain [ Time Frame: 4 months and 12 months post operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anterior Capsulectomy vs. Repair in Direct Anterior THA
Anterior Capsulectomy vs. Repair in Direct Anterior THA

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Total Hip Arthroplasty
  • Procedure: Direct anterior approach with capsulectomy
    Direct anterior approach with capsulectomy
  • Procedure: Direct anterior approach without capsulectomy
    Direct anterior approach without capsulectomy
  • Active Comparator: Surgical approach 1
    Direct anterior surgical approach with capsulectomy
    Intervention: Procedure: Direct anterior approach with capsulectomy
  • Active Comparator: Surgical approach 2
    Direct anterior approach without capsulectomy
    Intervention: Procedure: Direct anterior approach without capsulectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Susan M Odum, MEd 704.323.2265 susan.odum@orthocarolina.com
United States
 
NCT01621932
101105A
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Principal Investigator: John Masonis, MD OrthoCarolina, P.A.
OrthoCarolina Research Institute, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP