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

This study has been completed.
Medacta International SA
Information provided by (Responsible Party):
Medacta USA Identifier:
First received: July 31, 2009
Last updated: June 25, 2015
Last verified: June 2015
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 Intervention
Osteoarthritis Procedure: Anterior Approach Procedure: Posterior Approach

Study Type: Interventional
Study Design: 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

Further study details as provided by Medacta USA:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 64
Study Start Date: June 2009
Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Medacta USA Identifier: NCT00951951     History of Changes
Other Study ID Numbers: P0001
Study First Received: July 31, 2009
Last Updated: June 25, 2015

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 19, 2017