Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT04399304
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2020-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
Sponsor:
Bezmialem Vakif University
Organization:
Study Overview
Official Title:
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2020-05
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:
In this study, bilateral simultaneous high tibial osteotomy (HTO) was compared with staged bilateral HTO in terms of complications. We did not use any grafts to support the osteotomy line and the patients were mobilized immediately with a full load on a postoperative day 1. And our hypothesis is that bilateral simultaneous applications are safe in comparison to the staged ones in terms of complications.
Detailed Description:
Knee osteoarthritis is the most common orthopedic chronic disease, and varus knee abnormalities can often be related. The load from the medial tibiofemoral joint increases significantly in varus alignment disorder and it plays an important role in the structural progression of knee osteoarthritis. Varus malalignment and patients with medial tibiofemoral disease comprise a common patient subset. The probability of progressing to severe disease is 3 to 4 times higher in these patients compared to those with a neutral knee alignment. Although the long-term results of high tibial osteotomy are well documented, but data on bilateral simultaneous HTO are insufficient. In general, staged surgery is preferred in bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and complications related to surgery. Advances in post-surgical rehabilitation have been made due to increased confidence in stability due to improvements in the technology of plates.The advantages of an bilateral simulatneous HTO is single administration of anesthesia, total shortening of the hospitalization periof and reduced costs.
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?:
None
Is an FDA AA801 Violation?: