A Clinical Investigation of the Balance® Microplasty™ Hip System

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699088
• Other study ID #: Biomet 13594-117
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: January 2005
• Est. completion date: March 2013

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Orthopedic Specialty Clinic	Fredericksburg	Virginia
United States	Orthopaedic & Sports Medicine Clinic of Monroe	Monroe	Wisconsin
United States	Allegheny Health- Orthopedic Division	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score		5 years
Secondary	Incidence of revisions and removals		5 Years