Persona TM Tibia Clinical Outcomes Study

NCT03589300 | Completed Results FDA Device

• 1 other identifier: K.CR.I.G.16.33
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 7

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Radiograph Assessment of Progressive Tibial Radiolucencies

  Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5 mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.

  2 years

Secondary Outcomes (2)

• Oxford Knee Score

  2 years

• Revision Rate

  2 years

Study Arms (1)

Persona TM Tibia subjects

OTHER

Subjects that receive the Persona TM Tibia implant

Device: Persona TM Tibia

Interventions

Persona TM Tibia DEVICE

Trabecular Metal tibia used in primary cementless total knee arthroplasty

Persona TM Tibia subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years of age.
• 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:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
• Patient has participated in the study-related Informed Consent process.
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
• Independent of study participation, patient is a candidate for commercially available cementless Persona TM tibial knee component, implanted in accordance with product labeling.

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (7)

LA BioMed at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Cornerstone Orthopaedics & Sports Medicine, P.C.

Wheat Ridge, Colorado, 80033, United States

Location

Hawaii Pacific Health

Honolulu, Hawaii, 96813, United States

Location

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, 47362, United States

Location

Woods Mill Orthopedics, Ltd

Chesterfield, Missouri, 63017, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Zimmer Biomet

clinicaloperations@zimmerbiomet.com

800-613-6131

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 17, 2018
• Study Start: April 30, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)