Knee Arthroplasty Registry

• Conditions: Osteoarthritis, Knee
• Interventions: Device: any knee joint arthroplasty device

• Registration Number: NCT01132365
• Lead Sponsor: Heekin Orthopedic Research Institute

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-26
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7793

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
knee arthroplasty	any knee joint arthroplasty device	-

Primary Outcome Measures

Name	Time	Method
Knee Society Score	2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years

Trial Locations

Locations (1)

Heekin Orthopedic Specialists; 🇺🇸 Jacksonville, Florida, United States