ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00594893
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Craig J Delle Valle, Rush University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Procedure: Mini Incision Approach Procedure: 2 Incision Approach Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty
Study Start Date : June 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain scores [ Time Frame: Daily for 6 weeks postoperatively ]

Secondary Outcome Measures :
  1. Functional milestones [ Time Frame: daily for 6 weeks postoperatively ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00594893


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

Publications of Results:
Responsible Party: Craig J Delle Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00594893     History of Changes
Other Study ID Numbers: CDV-05061503
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Craig J Delle Valle, Rush University Medical Center:
Hip
Arthroplasty
Minimally Invasive

Additional relevant MeSH terms:
Osteoarthritis
Surgical Wound
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries