Knee Arthroplasty Registry

NCT ID: NCT01132365

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 7793 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2018-12-31

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

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

knee arthroplasty

any knee joint arthroplasty device

Intervention Type: DEVICE

Cohort consist of all consented patients receiving knee arthroplasty

Interventions

any knee joint arthroplasty device

Cohort consist of all consented patients receiving knee arthroplasty

Intervention Type: DEVICE

Other Intervention Names

Total Knee Arthoplasty; Unicondylar Knee arthroplasty; Revision Knee Arthroplasty

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 93 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Restor3D

INDUSTRY

Sponsor Role: collaborator

Heekin Orthopedic Research Institute

OTHER

Sponsor Role: lead

Responsible Party

R. David Heekin, MD

R. David Heekin, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard D Heekin, MD

Role: PRINCIPAL_INVESTIGATOR

Heekin Orthopedic Specialists

Locations

Heekin Orthopedic Specialists

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

05-05-02

Identifier Type: -

Identifier Source: org_study_id