High Tibial Osteotomy for Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

— HTO  

Official title:

High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977261
• Other study ID #: 2001-HTO
• Status: Completed
• Phase: N/A
• First received: October 25, 2013
• Last updated: October 30, 2013
• Start date: January 2001
• Est. completion date: April 2004

Study information

• Verified date: October 2013
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Radiological OA, medial joint pain and varus malalignment

Exclusion Criteria:

• Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM <100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture > 10 degrees.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Opening-wedge HTO
Opening-wedge high tibial osteotomy fixated with a Puddu plate
• Closing-wedge HTO
Closing-wedge high tibial osteotomy fixated with two staples

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Centre	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events	Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury.	one year	Yes
Primary	The achievement of an overcorrection of valgus of 4°.	The achieved correction will be determined on a whole leg radiograph.	one year	No
Secondary	Severity of pain	Severity of pain will be measured with the visual analogue scale	one year	No
Secondary	Knee function	Knee function will be measured with the Hospital for Special Surgery score	one year	No
Secondary	Walking distance		one year	No