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Clinical Trials
Disease or Condition   Osteoarthritis / Knee Replacement
Title   Evaluation of Oxford Unicompartmental Knee System Post Approval Study (Osteoarthritis / Knee replacement)
Description   The purpose of this study is to evaluate how well the Oxford™ Meniscal Unicompartmental Knee System works and how long it lasts.
IRB Number   Pro0081
Inclusion/Notes   INCLUSION:
  • Patients undergoing primary knee arthroplasty.

  • Patients with one of the following primary diagnoses in the medial compartment of the knee: a. Osteoarthritis, b. Avascular necrosis.

  • At least 18 years of age.

  • With intact and stable collateral ligaments.

  • There is a likelihood of obtaining relief of pain and improved function.

  • Patients who are able to follow post operative care instructions.

  • Patients who are willing and able to return for schedule follow-up evaluations.
  • All races and genders are eligible for enrollment.

  • Patients with a previous total knee replacement of the contralateral leg are eligible for participation in the study.

  • Patients in which anatomic alignment can be achieved.

  • Signs the Informed Consent Form.

EXCLUSION:
  • Patients who had previous prosthetic knee replacement device in the operative knee -- including unicondylar knee arthroplasty.

  • Who are less than 18 years of age.

  • Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

  • Patients with fused knee on operative side.

  • Infection, sepsis and osteomyelitis.

  • Rheumatoid arthritis or other forms of inflammatory joint disease.

  • Revision of a failed prosthesis, failed upper tibial osteotomy, or post-traumatic arthritis after tibial plateau fracture.

  • Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device.

  • Disease or damage to the lateral compartment of the knee.

  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

  • Metabolic disorders which impair bone formation: a. Paget's Disease, b. Osteomalacia c. Severe Osteoporosis.

  • Distant foci of infections which may spread to the implant site.

  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

  • Vascular insufficiency, muscular atrophy, neuromuscular disease.

  • Incomplete or deficient soft tissue surrounding the knee.

  • Charcot's disease.

  • A fixed varus deformity (not passively correctable) of greater that 15 degrees.

  • A flexion deformity greater than 15 degrees.

  • Patients who have not signed the IRB approved Informed Consent Form.
Status   Active - not Recruiting
Location   Texas Health Plano
Principal Name    Roger Hill Emerson MD
Contact Name   Mary Jenson
Phone   (972) 608-8868 ext 226

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