Minimally Invasive Surgery of the Hip Versus Standard Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261040
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : October 26, 2011
Zimmer Biomet
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

Condition or disease Intervention/treatment Phase
Hip Arthroplasty Osteoarthritis Procedure: minimally invasive total hip arthroplasty Procedure: Standard Not Applicable

Detailed Description:
Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Minimally Invasive Surgery of the Hip: A Randomized Study
Study Start Date : June 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: MIS
Minimally invasive hip surgery
Procedure: minimally invasive total hip arthroplasty
minimally invasive total hip arthroplasty
Other Name: non applicable

Active Comparator: Standard
Standard approach to hip surgery
Procedure: Standard
standard approach hip surgery
Other Name: non applicable

Primary Outcome Measures :
  1. Length of Stay [ Time Frame: Post-op ]

Secondary Outcome Measures :
  1. WOMAC SF-36 Harris Hip Get up and Go Operative Details Post-operative Complications [ Time Frame: Pre-op, 6, 12, 24 months post-op ]

Information from the National Library of Medicine

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

Inclusion Criteria:

BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

Exclusion Criteria:

Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc

Rheumatoid Arthritis

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 identifier (NCT number): NCT00261040

Sponsors and Collaborators
Ottawa Hospital Research Institute
Zimmer Biomet
Principal Investigator: Paul Kim, MD OHRI

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00261040     History of Changes
Other Study ID Numbers: OHREB 2003211-01H
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Ottawa Hospital Research Institute:
Total Hip Arthroplasty
Minimally Invasive Surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases