Osteoarthritis, Knee Clinical Trial
Official title:
A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee
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 |
Verified date | August 2020 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2019 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 40 years of age and older - Patients with OA Grade 1-4 (Kellgren-Lawrence) or osteonecrosis (ON) Stage 2-4 (according to the Koshino classification) - Indication for open wedge HTO with the TomoFix™ Small - No ligamental laxity - Able to understand and read country national language at an elementary level - Ability to understand the content of the patient information / informed consent form - Willingness and ability to participate in the registry according to the registry plan (RP) - Signed and dated IRB/EC-approved written informed consent Exclusion Criteria: - Femoro-tibial angle (FTA) > 190° (standing view x-ray) - Flexion contracture > 15° - Total knee replacement or unicompartmental knee on the contralateral side - Infections located between the middle of the femur and the ankle - Systemic bacterial infections - Severe osteoarthritis or surgery of the hip joint - Smoking of more than 20 cigarettes per day - Immunodeficiency or compromised host - Patients who have participated in any other device or drug related clinical trial within the previous month - ACL/PCL reconstruction of the same knee - Severe osteoarthritis of the ipsilateral ankle joint - HTO on the contralateral side - Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed) |
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 |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Publishing Documentation |
Japan,
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
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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