Biomet Humeral Stem Data Collection - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00553527

Purpose

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.

Condition	Intervention
Humeral Stem Replacement	Procedure: Humeral Stem replacement surgery

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Biomet Humeral Stem Data Collection

Resource links provided by NLM:

Drug Information available for: Cimetidine Cimetidine hydrochloride

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

The outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	July 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Patient will receive standard of care humeral stem replacement. Only a data collection study. There will be no changes in standard of care for diagnosis.	Procedure: Humeral Stem replacement surgery Patient will receive humeral stem replacement.

Detailed Description:

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.

All stems on which data will be collected are legally marketed and none of the devices are investigational or experimental. This data collection effort will document the clinical outcomes of the humeral stems. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Inclusion/Exclusion criteria are within the indications and contraindications stated in the labeling, cleared by the FDA, for the device. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling.

The outcomes and data collected include:

UCLA End-Result Score Radiographic Evaluation

Survivorship will be documented by asking the surgeon to record revisions, complications, and device related events.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid Arthritis
Correction of functional deformity
Patient selection factors to be considered:
1. Need to obtain pain relief and improve function
2. Ability and willingness of the patient to follow instructions, including control of weight and activity levels
3. A good nutritional state of the patient
4. The patient must have reached full skeletal maturity

Exclusion Criteria:

Patients who have infection, sepsis, and osteomyelitis
Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions
Patients who have osteoporosis
Patients who have metabolic disorders which may impair bone function
Patients with osteomalacia
Patients with distant foci of infections which may spread to the implant site
Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
Patients who are pregnant
Patients who are under 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553527

Locations

United States, Tennessee
Vanderbilt Hand Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Donald H Lee, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Dr. Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00553527 History of Changes
Other Study ID Numbers:	070144
Study First Received:	November 1, 2007
Last Updated:	August 5, 2009
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2012