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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02077647
Other study ID # FR_Tomofix
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date July 2019

Study information

Verified date August 2020
Source AO Innovation Translation Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The primary objective of this registry is to assess the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Nagasaki University Nagasaki city
Japan Osaka Koseinenkin Hospital Osaka
Japan Hashiba Orthopaedic Clinic Toyama-city
Japan Toyama Municipal Hospital Toyama-city

Sponsors (1)

Lead Sponsor Collaborator
AO Clinical Investigation and Publishing Documentation

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Takeuchi R, Aratake M, Bito H, Saito I, Kumagai K, Hayashi R, Sasaki Y, Akamatsu Y, Ishikawa H, Amakado E, Aota Y, Saito T. Clinical results and radiographical evaluation of opening wedge high tibial osteotomy for spontaneous osteonecrosis of the knee. Knee Surg Sports Traumatol Arthrosc. 2009 Apr;17(4):361-8. doi: 10.1007/s00167-008-0698-4. Epub 2009 Jan 23. — View Citation

Takeuchi R, Ishikawa H, Aratake M, Bito H, Saito I, Kumagai K, Akamatsu Y, Saito T. Medial opening wedge high tibial osteotomy with early full weight bearing. Arthroscopy. 2009 Jan;25(1):46-53. doi: 10.1016/j.arthro.2008.08.015. Epub 2008 Oct 10. — View Citation

Takeuchi R, Saito T, Koshino T. Clinical results of a valgus high tibial osteotomy for the treatment of osteoarthritis of the knee and the ipsilateral ankle. Knee. 2008 Jun;15(3):196-200. doi: 10.1016/j.knee.2008.02.002. Epub 2008 Mar 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Function of the knee Knee Injury and Osteoarthritis Outcome Score (KOOS) 24 months
Secondary Patient-evaluated function of the knee and quality of life Oxford-12-item knee score, WOMAC (as calculated from the KOOS) 6 months, 12 months, 24 months
Secondary Clinician-evaluated function of the knee Japanese Orthopaedic Association (JOA) score 6 months, 12 months, 24 months
Secondary Health-related quality of life Short Form-36 (SF-36) 6 months, 12 months, 24 months
Secondary Range of motion (ROM) 6 months, 12 months, 24 months
Secondary Local and general pain Visual Analogue Scale (VAS) 6 months, 12 months, 24 months
Secondary Possibility and duration of the Japanese sitting style 6 months, 12 months, 24 months
Secondary Return to sport activities 6 months, 12 months, 24 months
Secondary Utilization Length of hospital stay up to hospital discharge
Secondary Evaluation of degenerated and regenerated cartilage ICRS and Outerbridge / Koshino) intraoperative and after 2 years
Secondary Radiological parameters Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara 6 months, 12 months, 24 months
Secondary Complications Complications due to injections, complications due to heat therapy, complications due to medication (NSAIDs) 6 months, 12 months, 24 months
Secondary Anatomical alignment Femoro tibial angle (FTA) 6 months, 12 months, 24 months
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