Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr T M van Raaij

ORCID ID

Contact details

Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2; NTR483

Study information

Scientific title

Acronym

Closing HTO

Study hypothesis

Closing wedge osteotomy with plate fixation only will result in earlier mobilisation and better 1-year results considering pain and function then staple and cast fixation.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Arthritis, osteoarthritis

Intervention

Closing wedge high tibial osteotomy: staples and cast fixation versus TomoFix plate fixation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Is the accuracy of achieved correction of the mechanical limb axis post-operatively compared to the pre-operatively planned correction superior for closing wedge HTO with plate fixation?

Measurement:
Conservation of corrected angular limb deformity 1 year after surgery (success rate [%]). (Surgery is successful when the femoral-tibial axis 1 year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction.)

Secondary outcome measures

1. Does the functional outcome differ between the two bone defect implants? Measurement:
1.1. Knee range of motion (ROM)
1.2. Pain score (Visual Analogue Scale)
1.3. Hospital for Special Surgery (HHS) Knee Service Rating System
1.4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
1.5. Health-related quality-of-life score (EuroQol)
1.6. Complication
2. Which surgical technique is most efficient? Measurement: cost efficiency

Overall trial start date

01/08/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty
2. Above 18 years of age
3. Patient is knowledgeable and able to understand the treatment consequences
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92

Participant exclusion criteria

1. Mechanical axis not through the medial compartment (HipKneeAnkle angle greater than 180 degrees)
2. Rheumatoid arthritis
3. HipKneeAnkle angle less than 169 degrees
4. Range of motion (ROM) less than 100 degrees
5. Extension deficit 15 degrees
6. Collateral ligament insufficiency (instability grade 3)
7. Indication for a supracondylar femur osteotomy
8. Not able to speak or understand Dutch

Recruitment start date

01/08/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes