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A Clinical Investigation of the Taperloc® Microplasty™ Hip System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00699309
First received: June 13, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition
Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of revision or removals [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: August 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Taperloc® Microplasty™ Hip System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring relief from painful or disabling joint disease.

Criteria

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, and
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699309

Locations
United States, South Carolina
Low Country Bone & Joint Specialists
Beaufort, South Carolina, United States, 29902
Piedmont Orthopedics
Greenville, South Carolina, United States, 29615
United States, Texas
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
United States, Virginia
Arthritis & Sports Orthopaedics
Sterling, Virginia, United States, 20166
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00699309     History of Changes
Other Study ID Numbers: Biomet 13594-115
Study First Received: June 13, 2008
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Total Hip Replacement
Total Hip Arthroplasty
Minimally Invasive
Microplasty
Hip Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 23, 2013