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High Tibial Osteotomy for Osteoarthritis of the Knee (HTO)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Opening-wedge HTO
Closing-wedge HTO
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasmus Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Opening-wedge HTO

Closing-wedge HTO

Arm Description

Opening-wedge high tibial osteotomy fixated with a Puddu-plate

Closing-wedge high tibial osteotomy fixated with 2 staples

Outcomes

Primary Outcome Measures

The achievement of an overcorrection of valgus of 4°.
The achieved correction will be determined on a whole leg radiograph.

Secondary Outcome Measures

Severity of pain
Severity of pain will be measured with the visual analogue scale
Knee function
Knee function will be measured with the Hospital for Special Surgery score
Walking distance

Full Information

First Posted
October 25, 2013
Last Updated
October 30, 2013
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01977261
Brief Title
High Tibial Osteotomy for Osteoarthritis of the Knee
Acronym
HTO
Official Title
High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opening-wedge HTO
Arm Type
Experimental
Arm Description
Opening-wedge high tibial osteotomy fixated with a Puddu-plate
Arm Title
Closing-wedge HTO
Arm Type
Active Comparator
Arm Description
Closing-wedge high tibial osteotomy fixated with 2 staples
Intervention Type
Procedure
Intervention Name(s)
Opening-wedge HTO
Other Intervention Name(s)
open wedge high tibial osteotomy
Intervention Description
Opening-wedge high tibial osteotomy fixated with a Puddu plate
Intervention Type
Procedure
Intervention Name(s)
Closing-wedge HTO
Other Intervention Name(s)
Closed wedge high tibial osteotomy
Intervention Description
Closing-wedge high tibial osteotomy fixated with two staples
Primary Outcome Measure Information:
Title
The achievement of an overcorrection of valgus of 4°.
Description
The achieved correction will be determined on a whole leg radiograph.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Severity of pain
Description
Severity of pain will be measured with the visual analogue scale
Time Frame
one year
Title
Knee function
Description
Knee function will be measured with the Hospital for Special Surgery score
Time Frame
one year
Title
Walking distance
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands

12. IPD Sharing Statement

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High Tibial Osteotomy for Osteoarthritis of the Knee

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