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Clinical Trials/NCT01132365
NCT01132365
Unknown
Not Applicable

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

Heekin Orthopedic Research Institute1 site in 1 country7,793 target enrollmentApril 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Heekin Orthopedic Research Institute
Enrollment
7793
Locations
1
Primary Endpoint
Knee Society Score
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
December 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heekin Orthopedic Research Institute
Responsible Party
Principal Investigator
Principal Investigator

R. David Heekin, MD

R. David Heekin, M.D.

Heekin Orthopedic Research Institute

Eligibility Criteria

Inclusion Criteria

  • Patient is a male or non-pregnant female over the age of
  • Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
  • Patient has signed and dated an IRB approved consent form.
  • 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.
  • Patient has failed to respond to conservative treatment modalities.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Knee Society Score

Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years

Study Sites (1)

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