Biomet Humeral Stem Data Collection

This study has been terminated.

(Sponsor decided to terminate the project due to low multi-center enrollment.)

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00553527

First received: November 1, 2007

Last updated: August 5, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2007

Last Updated Date

August 5, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ]

Change History

Complete list of historical versions of study NCT00553527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biomet Humeral Stem Data Collection

Official Title ^ICMJE

Biomet Humeral Stem Data Collection

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Humeral Stem Replacement

Intervention ^ICMJE

Procedure: Humeral Stem replacement surgery

Patient will receive humeral stem replacement.

Study Arm (s)

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.

Intervention: Procedure: Humeral Stem replacement surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00553527

Other Study ID Numbers ^ICMJE

070144

Has Data Monitoring Committee

Responsible Party

Dr. Donald Lee, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Donald H Lee, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

August 2009

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

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