Comparing cemented and cementless knee replacement options
Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
NA · Zimmer Biomet · NCT05630053
This study is testing whether a new type of knee replacement that doesn't use cement works as well as the traditional cemented version for people needing knee surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet (industry) |
| Locations | 8 sites (Westminster, Colorado and 7 other locations) |
| Trial ID | NCT05630053 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, performance, and clinical benefits of two types of knee replacement systems: the cementless Persona OsseoTi Keel and the cemented Persona Keel. It is a prospective, multi-center, randomized controlled trial where participants will be randomly assigned to receive one of the two systems. Clinical evaluations will be conducted preoperatively and follow-up visits will occur at 3 months, 1 year, 2 years, and 5 years post-surgery. The study aims to enroll up to 300 participants across a maximum of 10 sites.
Who should consider this trial
Good fit: Ideal candidates include adults who are eligible for total knee arthroplasty and can provide informed consent.
Not a fit: Patients who are currently involved in other surgical interventions or pain management studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which knee replacement option offers better outcomes for patients with chronic knee pain and arthritis.
How similar studies have performed: Other studies comparing cemented and cementless knee replacement techniques have shown varying results, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is of legal age and skeletally mature 2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling. Exclusion Criteria: 1. Patient is unwilling to sign the Informed Consent 2. Patient is currently participating in any other surgical intervention or pain management study 3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients) 4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 5. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study 6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 7. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty Study Device-Specific Exclusion Criteria: 8. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint 9. Insufficient bone stock on femoral or tibial surfaces. 10. Neuropathic arthropathy 11. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 12. A stable, painless arthrodesis in a satisfactory functional position 13. Severe instability secondary to the absence of collateral ligament integrity 14. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 15. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
Where this trial is running
Westminster, Colorado and 7 other locations
- Centura Health — Westminster, Colorado, United States (RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
- Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
- Rothman Institute — Bryn Mawr, Pennsylvania, United States (RECRUITING)
- Lehigh Valley Hospital - Dickson City — Dickson City, Pennsylvania, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Darin Fawley
- Email: darin.fawley@zimmerbiomet.com
- Phone: 574-306-7230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity