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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Anterior Approach; Procedure: Posterior Approach

• Registration Number: NCT00951951
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Surgical Approach	Anterior Approach	(AMIS)
Posterior Approach Group	Posterior Approach	Posterior surgical approach for total hip replacement.

Primary Outcome Measures

Name	Time	Method
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.	Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Sun Valley Orthopedic Surgeons; 🇺🇸 Surprise, Arizona, United States

Intermountain Healthcare; 🇺🇸 Saint George, Utah, United States

D. Kevin Lester, MD; 🇺🇸 Fresno, California, United States

Peak Orthopedics; 🇺🇸 Lone Tree, Colorado, United States