Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2025-12-17 @ 10:35 PM
Study NCT ID:
NCT06250530
Status:
None
Last Update Posted:
2024-04-26 00:00:00
First Post:
2023-12-20 00:00:00
Brief Title:
Comparison Between TOMOFIX and BodyCAD Fine Osteotomy
Sponsor:
Western University Canada
Organization:
Western University, Canada
Study Overview
Official Title:
Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.
Status:
None
Status Verified Date:
2024-04
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:
None
Brief Summary:
The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy (MOWHTO) to either current standard of care, with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.
Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.
If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.
Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.
If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.
Detailed Description:
The proposed study is a single centre pilot randomised controlled patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy MOWHTO to either current standard of care with TOMOFIX plating system or utilise patient specific instrumentation and custom-made plate development with BodyCAD Fine Osteotomy Participants will follow a standardized rehabilitation protocol Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction bony union and construct stability as well as PROMs including KOOS and EQ5D
Complications adverse events returns to theatre and costs will also be recorded End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete
If the pilot study demonstrates the feasibility of the definitive trial an additional 110 participants will be ennrolled for a total of 150 participants
Complications adverse events returns to theatre and costs will also be recorded End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete
If the pilot study demonstrates the feasibility of the definitive trial an additional 110 participants will be ennrolled for a total of 150 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None