Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
Study NCT ID:
NCT05290818
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Sponsor:
NHS Lothian
Organization:
Study Overview
Official Title:
Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAKER
Brief 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.
Detailed Description:
Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment.
Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.
The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.
A single centre randomised control trial will be carried out powered to the Oxford knee score.
Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.
The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.
A single centre randomised control trial will be carried out powered to the Oxford knee score.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: