Trials / Active Not Recruiting
Active Not RecruitingNCT05630053
Cemented vs Cementless Persona Keel RCT
Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Detailed description
This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented).
Conditions
- Knee Pain Chronic
- Rheumatoid Arthritis
- Osteoarthritis
- Traumatic Arthritis
- Polyarthritis
- Avascular Necrosis
- Varus Deformity
- Valgus Deformity
- Flexion Deformity of Knee
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cementless Persona Knee System | The Persona Keel Knee system is a total knee system used in the replacement of the knee joint. |
| DEVICE | Cemented Persona Knee System | The Persona Keel Knee system is a total knee system used in the replacement of the knee joint. |
Timeline
- Start date
- 2023-07-25
- Primary completion
- 2032-05-01
- Completion
- 2032-12-01
- First posted
- 2022-11-29
- Last updated
- 2025-12-09
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05630053. Inclusion in this directory is not an endorsement.