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A Clinical Investigation of the Taperloc® Microplasty™ Hip System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00699309
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

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

Condition or disease
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System
Study Start Date : August 2005
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Taperloc® Microplasty™ Hip System

Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of revision or removals [ Time Frame: 5 Years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring relief from painful or disabling joint disease.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00699309

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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
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Study Director: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
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Responsible Party: Biomet Orthopedics, LLC Identifier: NCT00699309    
Other Study ID Numbers: Biomet 13594-115
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Total Hip Replacement
Total Hip Arthroplasty
Minimally Invasive
Hip Arthritis
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Pathologic Processes