Which knee implant lasts longer? a Head-to-Head test
NCT ID NCT02766231
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This study follows people with knee osteoarthritis who receive one of two total knee replacement designs: a cruciate-retaining (CR) or a posterior-stabilized (PS) implant. The goal is to compare how well each design relieves pain, restores function, and holds up over time. Researchers will track clinical scores, X-ray results, and patient-reported outcomes, as well as any complications, to see if one implant offers better long-term results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two types of total knee replacement prostheses: a cruciate-retaining (CR) design and a posterior-stabilized (PS) design
- What this could lead to
- If successful, this could help surgeons choose the best knee implant design for individual patients, improving long-term outcomes and satisfaction after knee replacement surgery.
- What could go wrong
- This is an observational post-market study, not a randomized controlled trial, so results may be influenced by patient selection. Outcomes depend on surgical technique and patient factors, and the study does not guarantee that one implant is superior.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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157 people
The number who actually took part.
- Started
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Feb 2016
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
General population of subjects requiring a primary TKR with a diagnosis of painful primary or secondary osteoartrithis not responding to other conservative treatments, after the review of medical history and the radiographic evaluation of the affected knee.
- Ages
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22 to 78 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and females 2. Age 22-78 years 3. Any race 4. Ambulatory patients 5. Patients who have a medical condition with over 5 years of life expectancy 6. Patients with painful primary or secondary knee osteoarthritis 7. Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS 8. Patients with flexion ≥90° on the affected side 9. Patients with a fixed flexion contracture \<20° 10. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits 11. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery Exclusion Criteria: 1. Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy 2. Primary Total Knee Replacement (TKR) in the affected knee 3. Varus deformity \>20° or Valgus deformity \>15° 4. Patients with a fixed flexion contracture \>20° 5. Previous intra-articular fractures of the affected knee 6. Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening. 7. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 60 points 8. Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is \>4 9. Patients with an history of infections (on the affected knee or systemic) 10. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance 11. Patients who have damaged or absence of the posterior cruciate ligament for the group requiring Physica CR 12. Patients with known or suspicious metal hypersensitivity 13. Recurrent medical history of severe allergic or immune-mediated reactions 14. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation 15. Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders 16. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including: 1. any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, drug or alcohol abuse 2. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery 3. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device 4. known metabolic disorders leading to progressive bone deterioration 17. Patients who have known co-existent medical condition with less 5 years of life expectancy 18. Previous organ transplant surgery 19. Any psychiatric illness that would prevent comprehension of the details and nature of the study 20. Participation in any experimental drug/device study within the 6 months prior to the screening visit 21. Female patients who are pregnant, nursing, or planning a pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Casa di cura Citta' di Parma
Parma, Parma, 43100, Italy
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Clinique d'Eich - centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1460, Luxembourg
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Cliniques Universitaires Saint-Luc ASBL
Brussels, Brussels Capital, 1200, Belgium
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I.R.C.C.S. Galeazzi
Milan, Milano, 20161, Italy
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