NCT03589300

Persona TM Tibia Clinical Outcomes Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	Persona TM Tibia	Trabecular Metal tibia used in primary cementless total knee arthroplasty

Timeline

• Start date: 2018-04-30
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2018-07-17
• Last updated: 2024-07-23
• Results posted: 2024-07-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study