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Clinical Trials/NCT00951951
NCT00951951
Completed
Not Applicable

Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial

Medacta USA4 sites in 1 country64 target enrollmentJune 2009
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Medacta USA
Enrollment
64
Locations
4
Primary Endpoint
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach.
Status
Completed
Last Updated
3 years ago

Overview

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 approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).

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 primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medacta USA
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach.

Time Frame: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year

Secondary Outcomes

  • Evaluate/compare two surgical approaches (direct anterior vs. posterior): Patient improvement (subjective and objective) following THA using the HHS. Patient overall function and pain following THA using the WOMAC. Post operative radiological findings(Pre-Op, 6 weeks, 3 months, 1 year)

Study Sites (4)

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