NCT00585988

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Status
withdrawn

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, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

December 21, 2007

Last Update Submit

June 19, 2017

Conditions

OsteoarthritisRheumatoid ArthritisArthritisTraumatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Functional Tests

    1 year

Study Arms (2)

1

OTHER
Device: Hip Resurfacing System

2

OTHER
Device: M2a-Magnum™ Large Metal Articulation

Interventions

Hip Resurfacing SystemDEVICE

This arm will utilize a hip resurfacing system.

1
M2a-Magnum™ Large Metal ArticulationDEVICE

This arm will utilize the M2a-Magnum™ implant system.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring hip arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
0

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

December 21, 2007

First Posted

January 4, 2008

Study Start

June 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

June 21, 2017

Record last verified: 2017-06