A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Total Knee Arthroplasty With Multigen Plus CCK Alone or Involving the AMF TT Cones.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female.

• Age ≥ 18 years old.

• Given written informed consent approved by the reference Ethics Committee (EC).

• Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.

• Subjects able to comply with the Study Protocol.

Locations
Other Locations
Portugal
Hospital Senhora da Oliveira in Guimarães
RECRUITING
Guimarães
Slovakia
Saints Cyril and Methodius Hospital
RECRUITING
Bratislava
United Kingdom
Royal Devon and Exeter Hospital
RECRUITING
Exeter
Contact Information
Primary
Francesca Citossi, CIS Manager Europe & APAC
francesca.citossi@limacorporate.com
+39 335 1640260
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2026-07
Participants
Target number of participants: 68
Treatments
Multigen Plus CCK
Multigen Plus CCK in combination with AMF TT cones
Related Therapeutic Areas
Sponsors
Leads: Limacorporate S.p.a

This content was sourced from clinicaltrials.gov