A Clinical Investigation of the Taperloc® Microplasty™ Hip System

This study is ongoing, but not recruiting participants.

First Received: June 13, 2008 Last Updated: December 19, 2008 History of Changes

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00699309

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

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 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:

Kenneth J Beres, MD

Director, Clinical Research, Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research )
Study ID Numbers:	Biomet 13594-115
Study First Received:	June 13, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00699309 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Hip Replacement
Total Hip Arthroplasty
Minimally Invasive
Microplasty
Hip Arthritis

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009