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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 31, 2012
August 1, 2012
4.5 years
January 7, 2008
August 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain scores
Daily for 6 weeks postoperatively
Secondary Outcomes (1)
Functional milestones
daily for 6 weeks postoperatively
Study Arms (2)
1
ACTIVE COMPARATORMini Incision Approach
2
ACTIVE COMPARATOR2 Incision Approach
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- Zimmer Biometcollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Related Publications (1)
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. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.
PMID: 20668969RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig J DellaValle, MD
Rush University Medical Center, Department of Orthopaedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
June 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 31, 2012
Record last verified: 2012-08