Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty
This study is currently recruiting participants.
Verified September 2012 by Medacta USA
Sponsor:
Medacta USA
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
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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 |
Resource links provided by NLM:
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
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 May 22, 2013