Clinical trial NCT01132365: Knee Arthroplasty Registry
Official title: Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Keywords: knee arthroplasty
Lead sponsor: Heekin Orthopedic Research Institute
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
name: Stryker Orthopaedics
name: Restor3D
First posted: 2010-05-28
Enrollment: 7793
Sex: ALL
Minimum age (years): 21
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male and non-pregnant females undergoing knee arthroplasty.

Brief summary: Objective

Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.

Examine the relationship between processes of care, hospital and surgeon associated outcomes.

Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.

Analyze and design ancillary studies to address unanswered questions.

Disseminate findings through publication in peer-reviewed scientific journals.

Detailed description: Population: All male and non-pregnant females undergoing knee arthroplasty.

Study Design: Prospective, consecutive series on an unlimited number of patients.

Data Collection

Clinic Data:

Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results

Surgical Data:

Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results

Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view

Eligibility criteria: Inclusion Criteria:

1. Patient is a male or non-pregnant female over the age of 21.
2. Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
3. Patient has signed and dated an IRB approved consent form.
4. Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
5. Patient has failed to respond to conservative treatment modalities.

Exclusion Criteria:

1. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
2. Patient is a prisoner.

Primary outcomes:
measure: Knee Society Score
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Heekin Orthopedic Specialists
state: Florida
Study officials:
affiliation: Heekin Orthopedic Specialists
name: Richard D Heekin, MD
role: PRINCIPAL_INVESTIGATOR
References: