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Completed

NCT Number: NCT00951951

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

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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Valley Orthopedic Surgeons, Surprise, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior Approach

Procedure

Anterior Minimal Invasive Surgery (AMIS)

Posterior Approach

Procedure

Other names: Posterior Surgical Approach

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Collaborators

  • Medacta International SA

Registry information

Official study title

Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Aug 4, 2009
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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