Study of an All Polyethylene Tibial Component

Status Active, not recruiting

Clinical Trial Summary

This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.

Clinical Trial Description

Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.

The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects. ;

Study Design

Related Conditions & MeSH terms

Knee Replacement

Clinical Trial Details

NCT number	NCT02540902
Study type	Interventional
Source	Golden Jubilee National Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 2015
Completion date	October 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05635916` - Trial of Liposomal Bupivacaine for TKA	Phase 4
Withdrawn	`NCT04099355` - Investigating the Effect of Dronabinol on Post-surgical Pain	Early Phase 1
Recruiting	`NCT04199377` - Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.	N/A
Recruiting	`NCT04167787` - Intelligent Operating Room (InOR) for Orthopaedic Surgery
Completed	`NCT03633097` - Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement	N/A
Recruiting	`NCT02188199` - C3 Total Joint Patient Registry	N/A
Completed	`NCT00328939` - ARIXTRA Local Study For Registration In China.	Phase 3
Recruiting	`NCT03130309` - Results of a Mobile Unicompartimental Knee Prosthesis
Not yet recruiting	`NCT02651571` - Survival Rates of Patients With Mobile Bearing Total Knee Arthroplasty After 10 Years	N/A
Recruiting	`NCT04314505` - Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty	Phase 4
Completed	`NCT03848520` - Survey of Running Following a TKA
Completed	`NCT02704182` - Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty	N/A
Recruiting	`NCT05459948` - The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Active, not recruiting	`NCT04198389` - Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small Implants	N/A
Completed	`NCT03072459` - A Retrospective Study of the Navio Robotic-assisted Surgical System
Completed	`NCT03120052` - Physical Therapy Components for Maximum TKR Outcome
Completed	`NCT03434600` - Comparison of Oxford UKA and Sigma UKA With RSA.	N/A
Completed	`NCT04016285` - Total Knee Replacement With Tourniquet or Aquamantys	N/A
Completed	`NCT05184725` - CARINAE for Stress Relief in Perioperative Care	N/A
Completed	`NCT02920151` - Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty	N/A