Status:
COMPLETED
Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty
Lead Sponsor:
Medacta USA
Collaborating Sponsors:
Medacta International SA
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approac...
Detailed Description
This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of prim...
Eligibility Criteria
Inclusion
- Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
- Those presenting with primary or secondary osteoarthritis
- Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)
Exclusion
- Pregnant women or women who plan to conceive within the year following surgery
- Inflammatory arthritic condition
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- Those already treated with a failed Total Hip Arthroplasty (THA)
- Muscle contracture around the hip joint
- Individuals who have undergone organ transplant
- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
- Individuals who have had a THA on the contra-lateral side within the 6 months.
- Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
- Individuals requiring bilateral hip replacement
- Individuals whose body mass index (BMI; kg/m2) \>40
- Individuals with active or suspected infection or sepsis
- Individuals with chronic renal failure as defined by the need for dialysis
- Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
- History of drug and/or substance abuse
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00951951
Start Date
June 1 2009
End Date
December 1 2014
Last Update
May 19 2022
Active Locations (4)
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1
Sun Valley Orthopedic Surgeons
Surprise, Arizona, United States, 85374
2
D. Kevin Lester, MD
Fresno, California, United States, 93710
3
Peak Orthopedics
Lone Tree, Colorado, United States, 80124
4
Intermountain Healthcare
St. George, Utah, United States, 84790