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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

June 13, 2008
March 19, 2013
August 2005
March 2013   (final data collection date for primary outcome measure)
Harris Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
  • X-rays [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00699309 on ClinicalTrials.gov Archive Site
Incidence of revision or removals [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Clinical Investigation of the Taperloc® Microplasty™ Hip System
A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients requiring relief from painful or disabling joint disease.
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Avascular Necrosis
Not Provided
Taperloc® Microplasty™ Hip System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00699309
Biomet 13594-115
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Study Director: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
Biomet, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP