Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty

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. Identifier: NCT00951951
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : June 26, 2015
Medacta International SA
Information provided by (Responsible Party):
Medacta USA

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Anterior Approach Procedure: Posterior Approach Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial
Study Start Date : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Anterior Surgical Approach
Procedure: Anterior Approach
Anterior Minimal Invasive Surgery (AMIS)

Active Comparator: Posterior Approach Group
Posterior surgical approach for total hip replacement.
Procedure: Posterior Approach
Other Name: Posterior Surgical Approach

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: Pre-Op, 6 weeks, 3 months, 1 year ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

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 identifier (NCT number): NCT00951951

United States, Arizona
Sun Valley Orthopedic Surgeons
Surprise, Arizona, United States, 85374
United States, California
D. Kevin Lester, MD
Fresno, California, United States, 93710
United States, Colorado
Peak Orthopedics
Lone Tree, Colorado, United States, 80124
United States, Utah
Intermountain Healthcare
St. George, Utah, United States, 84790
Sponsors and Collaborators
Medacta USA
Medacta International SA
Study Director: Tyler Goldberg, MD Medacta USA Medical Director

Additional Information:
Responsible Party: Medacta USA Identifier: NCT00951951     History of Changes
Other Study ID Numbers: P0001
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases