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

January 7, 2008
August 29, 2012
June 2006
December 2010   (final data collection date for primary outcome measure)
Pain scores [ Time Frame: Daily for 6 weeks postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594893 on ClinicalTrials.gov Archive Site
Functional milestones [ Time Frame: daily for 6 weeks postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing Mini-Incision Versus 2-Incision Approach for Total Hip Replacement
A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Osteoarthritis
  • Procedure: Mini Incision Approach
    Mini Incision Approach
  • Procedure: 2 Incision Approach
    2 Incision Approach
  • Active Comparator: 1
    Mini Incision Approach
    Intervention: Procedure: Mini Incision Approach
  • Active Comparator: 2
    2 Incision Approach
    Intervention: Procedure: 2 Incision Approach
Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. Epub 2010 Jul 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594893
CDV-05061503
No
Craig J Delle Valle, Rush University Medical Center
Rush University Medical Center
Zimmer, Inc.
Principal Investigator: Craig J DellaValle, MD Rush University Medical Center, Department of Orthopaedics
Rush University Medical Center
August 2012

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