Knee Arthroplasty Registry

Osteoarthritis, Knee Clinical Trial

Official title:

Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01132365
• Other study ID #: 05-05-02
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 26, 2010
• Last updated: July 22, 2016
• Start date: April 2005
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Heekin Orthopedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7793
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 93 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• any knee joint arthroplasty device
Cohort consist of all consented patients receiving knee arthroplasty

Locations

Country	Name	City	State
United States	Heekin Orthopedic Specialists	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Heekin Orthopedic Research Institute	ConforMIS, Inc., DePuy Orthopaedics, Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years	No