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Knee Arthroplasty Registry

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
DePuy Orthopaedics
Stryker Orthopaedics
ConforMIS, Inc.
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01132365
First received: May 26, 2010
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
 Device: any knee joint arthroplasty device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heekin Orthopedic Research Institute:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3156
Study Start Date: April 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
knee arthroplasty Device: any knee joint arthroplasty device
Cohort consist of all consented patients receiving knee arthroplasty
Other Names:
  • Total Knee Arthoplasty
  • Unicondylar Knee arthroplasty
  • Revision Knee Arthroplasty

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All male and non-pregnant females undergoing knee arthroplasty.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132365

Locations
United States, Florida
Heekin Orthopedic Specialists
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
Heekin Orthopedic Research Institute
DePuy Orthopaedics
Stryker Orthopaedics
ConforMIS, Inc.
Investigators
Principal Investigator: Richard D Heekin, MD Heekin Orthopedic Specialists
  More Information

No publications provided

Responsible Party: R. David Heekin, R. David Heekin, M.D., Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01132365     History of Changes
Other Study ID Numbers: 05-05-02
Study First Received: May 26, 2010
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Heekin Orthopedic Research Institute:
knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 13, 2013