NCT01977261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

3.2 years

First QC Date

October 25, 2013

Last Update Submit

October 30, 2013

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The achievement of an overcorrection of valgus of 4°.

    The achieved correction will be determined on a whole leg radiograph.

    one year

Secondary Outcomes (3)

  • Severity of pain

    one year

  • Knee function

    one year

  • Walking distance

    one year

Other Outcomes (1)

  • Number of participants with adverse events

    one year

Study Arms (2)

Opening-wedge HTO

EXPERIMENTAL

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

Procedure: Opening-wedge HTO

Closing-wedge HTO

ACTIVE COMPARATOR

Closing-wedge high tibial osteotomy fixated with 2 staples

Procedure: Closing-wedge HTO

Interventions

Opening-wedge HTOPROCEDURE

Opening-wedge high tibial osteotomy fixated with a Puddu plate

Also known as: open wedge high tibial osteotomy
Opening-wedge HTO
Closing-wedge HTOPROCEDURE

Closing-wedge high tibial osteotomy fixated with two staples

Also known as: Closed wedge high tibial osteotomy
Closing-wedge HTO

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiological OA, medial joint pain and varus malalignment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Centre

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 6, 2013

Study Start

January 1, 2001

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

November 6, 2013

Record last verified: 2013-10

Locations

NL(1)