Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Louis M Kwong(ucla)

Description

Summary

The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.

Official Title

Persona® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the Persona® Trabecular Metal Tibia

Details

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device,and adverse event data.

The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.

The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:

  • No revisions for any reason
  • Oxford Knee Score >38

Keywords

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Polyarthritis Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle Post-traumatic Loss of Joint Configuration Moderate Valgus, Varus, or Flexion Deformities Arthritis Rheumatic Diseases Collagen Diseases Necrosis Persona TM Tibia

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient is at least 18 years of age.
  2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
  3. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  4. Collagen disorders and/or avascular necrosis of the femoral condyle.
  5. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
  6. Moderate valgus, varus, or flexion deformities.
  7. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
  8. Patient has participated in the study-related Informed Consent process.
  9. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
  10. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
  11. Independent of study participation, patient is a candidate for commercially available cementless Persona TM tibial knee component, implanted in accordance with product labeling.

You CAN'T join if...

  1. Previous history of infection in the affected joint.
  2. Active local or systemic infection that may affect the prosthetic joint.
  3. Insufficient bone stock on femoral or tibial surfaces.
  4. Skeletal immaturity.
  5. Neuropathic arthropathy.
  6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
  7. A stable, painless arthrodesis in a satisfactory functional position.
  8. Severe instability secondary to the absence of collateral ligament integrity.
  9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
  10. . Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
  11. . Patient is currently participating in any other surgical intervention studies or pain management studies.
  12. . Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
  13. . Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.

Locations

  • LA BioMed at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Cornerstone Orthopaedics & Sports Medicine, P.C. not yet accepting patients
    Wheat Ridge Colorado 80033 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zimmer Biomet
ID
NCT03589300
Study Type
Interventional
Last Updated