NCT00951951

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

4.5 years

First QC Date

July 31, 2009

Last Update Submit

May 18, 2022

Conditions

Osteoarthritis

Outcome Measures

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.

    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

    Pre-Op, 6 weeks, 3 months, 1 year

Study Arms (2)

Anterior Surgical Approach

ACTIVE COMPARATOR

(AMIS)

Procedure: Anterior Approach

Posterior Approach Group

ACTIVE COMPARATOR

Posterior surgical approach for total hip replacement.

Procedure: Posterior Approach

Interventions

Anterior ApproachPROCEDURE

Anterior Minimal Invasive Surgery (AMIS)

Anterior Surgical Approach
Posterior ApproachPROCEDURE
Also known as: Posterior Surgical Approach
Posterior Approach Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sun Valley Orthopedic Surgeons

Surprise, Arizona, 85374, United States

Location

D. Kevin Lester, MD

Fresno, California, 93710, United States

Location

Peak Orthopedics

Lone Tree, Colorado, 80124, United States

Location

Intermountain Healthcare

St. George, Utah, 84790, United States

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tyler Goldberg, MD

    Medacta USA Medical Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 4, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

US(4)