A Clinical Investigation of the Balance® Microplasty™ Hip System

NCT00699088 | Completed

• 1 other identifier: Biomet 13594-117
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis

Keywords

Total Hip Arthroplasty; Total Hip Replacement; Minimally Invasive; Microplasty

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  5 years

Secondary Outcomes (1)

• Incidence of revisions and removals

  5 Years

Study Arms (1)

Balance® Microplasty™ Hip System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring relief from painful or disabling joint disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

Study Sites (4)

University of Chicago

Chicago, Illinois, 60640, United States

Location

Allegheny Health- Orthopedic Division

Pittsburgh, Pennsylvania, 15212, United States

Location

Orthopedic Specialty Clinic

Fredericksburg, Virginia, 22401, United States

Location

Orthopaedic & Sports Medicine Clinic of Monroe

Monroe, Wisconsin, 53566, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell Schenck, PhD

  Director, Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: January 1, 2005
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

US (4)