Trials / Terminated
TerminatedNCT04594447
Physica System KR Vs Physica System CR (K-20)
A Post-market,monocentric,randomised,open-label,parallel Group,prospective Clinical Study Evaluating the Functional Outcome of the Kinematic Physica KR Total Knee Replacement System Vs the Standard Physica CR Total Knee Replacement System
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Limacorporate S.p.a · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.
Detailed description
The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Physica Kinematic Retaining knee replacement | modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation |
| DEVICE | Physica Cruciate Retaining knee replacement | modular knee prosthesis with posterior cruciate ligament (PCL) preservation |
Timeline
- Start date
- 2021-09-30
- Primary completion
- 2024-04-01
- Completion
- 2024-04-01
- First posted
- 2020-10-20
- Last updated
- 2025-03-10
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04594447. Inclusion in this directory is not an endorsement.