A Clinical Investigation of the Taperloc® Microplasty™ Hip System

Last updated: June 19, 2017
Sponsor: Biomet Orthopedics, LLC
Overall Status: Completed

Phase

N/A

Condition

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00699309
Biomet 13594-115
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascularnecrosis

  • Rheumatoid arthritis.

  • Correction of functional deformity.

  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of theproximal femur with head involvement, unmanageable by other techniques.

  • Revision of previously failed femoral head resurfacing component

Exclusion

Exclusion Criteria: Absolute contraindications include:

  • infection,

  • sepsis, and

  • osteomyelitis. Relative contraindications include:

  • uncooperative patient or patient with neurologic disorders who are incapable offollowing 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 onroentgenogram,

  • vascular insufficiency, muscular atrophy, or neuromuscular disease.

Study Design

Total Participants: 98
Study Start date:
August 01, 2005
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Low Country Bone & Joint Specialists

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Piedmont Orthopedics

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Texas Center for Joint Replacement

    Plano, Texas 75093
    United States

    Site Not Available

  • Arthritis & Sports Orthopaedics

    Sterling, Virginia 20166
    United States

    Site Not Available

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