A Clinical Investigation of the Balance® Microplasty™ Hip System

Verified by: Biomet, Inc., August 2011
First Received: June 13, 2008 | Last Updated: August 23, 2011 | Phase: N/A | Start Date: January 2005
Overall Status: Active, not recruiting | Estimated Enrollment: 70
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The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System...

Brief Summary

Official Title: “A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System”

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

Arms, Groups and Cohorts in this Clinical Trial

  • : Balance® Microplasty™ Hip System

Outcome Measures for this Clinical Trial

Primary Measures

  • Harris Hip Score
    • Time Frame: 5 years
      Safety Issue?: No

Secondary Measures

  • Incidence of revisions and removals
    • Time Frame: 5 Years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis.
  • Correction of functional deformity.
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
  • Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

  • infection,
  • sepsis,
  • osteomyelitis.

Relative contraindications include:

  • uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • osteoporosis,
  • metabolic disorders which may impair bone formation,
  • osteomalacia,
  • distant foci of infections which may spread to the implant site,
  • rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  • vascular insufficiency, muscular atrophy, or neuromuscular disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

Russell Schenck, PhD Study Director Director, Clinical Research, Biomet Orthopedics, LLC  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699088

Study ID Number: Biomet 13594-117

ClinicalTrials.gov Identifier: NCT00699088

Health Authority: United States: Institutional Review Board

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00699088