Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• Listed for elective primary TKA for end stage medial compartment osteoarthritis

• Intact anterior cruciate ligament

• Full thickness and good quality lateral cartilage

• Correctable intra-articular varus deformity and intact medial collateral ligament

• American Society of Anesthesiologists (ASA) grades 1 and 2

• Male or female, age 50 - 75 at the time of listing for surgery

• Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA

Locations
Other Locations
United Kingdom
Nicholas Clement
RECRUITING
Edinburgh
Contact Information
Primary
Nicholas D Clement, MD, PhD
nick.clement@nhslothian.scot.nhs.uk
+44 131 536 1000
Backup
James T Patton, FRCS
Sam.Patton@nhslothian.scot.nhs.uk
+44 131 536 1000
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 159
Treatments
Active_comparator: Manual Total Knee Arthroplasty
This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the feel though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.
Experimental: Robotic Assisted Unicompartmental Knee Arthroplasty
This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.
Sponsors
Leads: NHS Lothian

This content was sourced from clinicaltrials.gov