Closing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus Tomofix plate fixation. A randomised trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20412

Enrollment

Registered

2005-09-15

Start date

2004-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

randomised controlled trial

Interventions

Closing wedge high tibial osteotomy.

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Mechanical axis not through the medial compartment (HipKneeAnkle angle > 180¢ª); 2. Rheumatoid arthritis; 3. HipKneeAnkle angle < 169¨¬; 4. ROM < 100¢ª; 5. Extension deficit 15¨¬; 6. Collateral ligament insufficiency (instability grade 3); 7. Indication for a supracondylar femur osteotomy; 8. Not able to speak or understand Dutch.

Design outcomes

Primary

Measure	Time frame
Is the accuracy of achieved correction of the mechanical limb axis postoperatively compared to the preoperatively planned correction superior for closing wedge HTO with plate fixation? Measurement: 1. Conservation of corrected angular limb deformity one year after surgery (success rate (%)). (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).	—

Measure

Time frame

Is the accuracy of achieved correction of the mechanical limb axis postoperatively compared to the preoperatively planned correction superior for closing wedge HTO with plate fixation? Measurement: 1. Conservation of corrected angular limb deformity one year after surgery (success rate (%)). (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).

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Secondary

Measure	Time frame
I- Does the functional outcome differ between the two bone defect implants? Measurement: 1. Knee range of motion (ROM); 2. Pain score (Visual Analogue Scale); 3. Hospital for Special Surgery (HHS) Knee Service Rating System; 4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC); 5. Health related quality-of-life score (EuroQol); 6. Complication. II - Which surgical technique is most efficient? Measurement: 7. Cost efficiency.	—

Measure

Time frame

I- Does the functional outcome differ between the two bone defect implants? Measurement: 1. Knee range of motion (ROM); 2. Pain score (Visual Analogue Scale); 3. Hospital for Special Surgery (HHS) Knee Service Rating System; 4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC); 5. Health related quality-of-life score (EuroQol); 6. Complication. II - Which surgical technique is most efficient? Measurement: 7. Cost efficiency.

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Contacts

Public ContactT.M. Raaij, van

Erasmus University Medical Center, Department of Orthopaedic Surgery, P.O. Box 2040

t.vanraaij@chello.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)