Clinical trial NCT00553527: Biomet Humeral Stem Data Collection
Official title: Biomet Humeral Stem Data Collection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Humeral Stem Replacement
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-11-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: The outcome will be measured using the data collection sheets collected at each follow-up visit.
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Hand Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Donald H Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: