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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medacta USA.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medacta International SA
Information provided by (Responsible Party):
Medacta USA
ClinicalTrials.gov Identifier:
NCT00951951
First received: July 31, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior Surgical Approach
(AMIS)
Procedure: Anterior Approach
Anterior Minimal Invasive Surgery (AMIS)
Active Comparator: Posterior Approach Group 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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 ClinicalTrials.gov identifier: NCT00951951

Contacts
Contact: Todd Curry 512-638-3242 tcurry@hccrsite.com
Contact: Tyler Goldberg, MD 512-439-1000 tgoldberg@texasorthopedics.com

Locations
United States, Arizona
Sun Valley Orthopedic Surgeons Recruiting
Surprise, Arizona, United States, 85374
Principal Investigator: Joseph Janzer, DO         
United States, California
D. Kevin Lester, MD Recruiting
Fresno, California, United States, 93710
Principal Investigator: D. Kevin Lester, MD         
United States, Colorado
Peak Orthopedics Active, not recruiting
Lone Tree, Colorado, United States, 80124
United States, Utah
Intermountain Healthcare Active, not recruiting
St. George, Utah, United States, 84790
Sponsors and Collaborators
Medacta USA
Medacta International SA
Investigators
Study Director: Tyler Goldberg, MD Medacta USA Medical Director
  More Information

Additional Information:
No publications provided

Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT00951951     History of Changes
Other Study ID Numbers: P0001
Study First Received: July 31, 2009
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014