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Which knee implant lasts longer? a Head-to-Head test

NCT ID NCT02766231

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

157 people

The number who actually took part.

Started

Feb 2016

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

22 to 78 years

Sex

Anyone

Healthy volunteers

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

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

  • Casa di cura Citta' di Parma

    Parma, Parma, 43100, Italy

  • Clinique d'Eich - centre Hospitalier de Luxembourg

    Luxembourg, Luxembourg, 1460, Luxembourg

  • Cliniques Universitaires Saint-Luc ASBL

    Brussels, Brussels Capital, 1200, Belgium

  • I.R.C.C.S. Galeazzi

    Milan, Milano, 20161, Italy

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