Clinical Trials Logo

Clinical Trial Summary

In this project the investigators wish to:

Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.

This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.

Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After the 2 year follow-up visit the patients will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively.


Clinical Trial Description

The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.

The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.

Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.

Participants will receive standard pain treatment and rehabilitation until discharge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03495232
Study type Observational
Source Zimmer Biomet
Contact Emilie JL Aas
Phone 0047 90649077
Email emilie.aas@zimmerbiomet.com
Status Recruiting
Phase
Start date November 1, 2016
Completion date December 31, 2032

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03665233 - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty N/A
Enrolling by invitation NCT03605290 - Comparison Between Two Operational Techniques for Total Knee Replacement N/A
Not yet recruiting NCT03528564 - Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia Phase 2
Recruiting NCT03230942 - Effect of Pre-op Patient Education on Functional Outcomes After TKA N/A
Enrolling by invitation NCT03302832 - Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty N/A
Recruiting NCT03454256 - Virtual Reality Rehabilitation in Patients With Total Knee Replacement N/A
Recruiting NCT03470649 - Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients N/A
Recruiting NCT03148951 - The Relation of MPV and NLR With Postoperative Pain in Patients Undergoing Total Knee Arthroplasty N/A
Completed NCT01306370 - Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty Phase 3
Completed NCT03659318 - Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA) Phase 4
Recruiting NCT03106129 - Opioid Requirements Post Discharge of Patients Having Total Knee Arthroplasty (TKA) N/A
Recruiting NCT03094663 - Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI) N/A
Recruiting NCT03032679 - Pain and Impact of Chronic Pain on Function After Total Knee Replacements
Not yet recruiting NCT03541798 - Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia N/A
Completed NCT03114306 - Evaluation of a Fast-track Knee Arthroplasty Concept N/A
Completed NCT03143738 - Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty N/A
Terminated NCT03058393 - Analyzing Challenging Clinical Discussions in Orthopaedics N/A