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Study Comparing Mini-Incision Versus 2-Incision Approach for Total Hip Replacement

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Craig J Delle Valle, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00594893
First received: January 7, 2008
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). It is unclear which of these techniques is associated with a faster recovery and lower risk of complications.


Condition Intervention
Osteoarthritis
 Procedure: Mini Incision Approach
Procedure: 2 Incision Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Pain scores [ Time Frame: Daily for 6 weeks postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional milestones [ Time Frame: daily for 6 weeks postoperatively ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mini Incision Approach
 Procedure: Mini Incision Approach
Mini Incision Approach
Active Comparator: 2
2 Incision Approach
 Procedure: 2 Incision Approach
2 Incision Approach

Detailed Description:

Recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. Proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. Among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance.

While the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. Proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. The goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.

  Eligibility

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

Inclusion Criteria:

  • diagnosis of hip osteoarthritis
  • age greater than 18 years
  • willingness to undergo a neuraxial anesthetic for the procedure
  • female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception

Exclusion Criteria:

  • use of any medication that may impact platelet aggregation within 10 days of surgery
  • chronic use of coumadin for anticoagulation
  • the use of low molecular weight heparin postoperatively
  • clinically significant systemic disease or laboratory abnormalities
  • a primary hematologic disorder
  • recent gastrointestinal or intracranial bleeding
  • any contraindication to anticoagulant use
  • history of previous ipsilateral hip surgery
  • a body mass index of greater than 30
  • significant hip deformity that precludes the use of standard implants
  • use of ONLY general anesthetic during surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594893

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Zimmer, Inc.
Investigators
Principal Investigator: Craig J DellaValle, MD Rush University Medical Center, Department of Orthopaedics
  More Information

Publications:

Responsible Party: Craig J Delle Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00594893     History of Changes
Other Study ID Numbers: CDV-05061503
Study First Received: January 7, 2008
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Hip
Arthroplasty
Minimally Invasive

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013