Viewing Study NCT01977261


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Study NCT ID: NCT01977261
Status: COMPLETED
Last Update Posted: 2013-11-06
First Post: 2013-10-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: High Tibial Osteotomy for Osteoarthritis of the Knee
Sponsor: Erasmus Medical Center
Organization:

Study Overview

Official Title: High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial
Status: COMPLETED
Status Verified Date: 2013-10
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: HTO
Brief Summary: A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.
Detailed Description: A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: