A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty

June 19, 2017 updated by: Biomet Orthopedics, LLC

Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level

The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring hip arthroplasty

Exclusion Criteria:

  • Patients with sensory, neurological, or general health conditions that alter perception of their limb in space
  • Patients with vestibular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Device: Hip Resurfacing System
This arm will utilize a hip resurfacing system.
OTHER: 2
Device: M2a-Magnum™ Large Metal Articulation
This arm will utilize the M2a-Magnum™ implant system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Tests
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomet Orthopedics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (ESTIMATE)

January 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292-U-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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