Minimally Invasive Surgery of the Hip Versus Standard Approach

This study has been completed.

Sponsor:

Collaborator:

Zimmer, Inc.

Information provided by (Responsible Party):

Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT00261040

First received: November 30, 2005

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention
Hip Arthroplasty Osteoarthritis	Procedure: minimally invasive total hip arthroplasty Procedure: Standard

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	Minimally Invasive Surgery of the Hip: A Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

Length of Stay [ Time Frame: Post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC SF-36 Harris Hip Get up and Go Operative Details Post-operative Complications [ Time Frame: Pre-op, 6, 12, 24 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2003
Study Completion Date:	May 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261040

Sponsors and Collaborators

Ottawa Hospital Research Institute

Zimmer, Inc.

Investigators

Principal Investigator:

Paul Kim, MD

OHRI

More Information

No publications provided

Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00261040 History of Changes
Other Study ID Numbers:	OHREB 2003211-01H
Study First Received:	November 30, 2005
Last Updated:	October 24, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:

Osteoarthritis
Total Hip Arthroplasty
Minimally Invasive Surgery

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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