An observational study in Osteoarthritis, Knee and Osteonecrosis, sponsored by Synthes GmbH. Completed at 1 site in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Synthes GmbH (part of Johnson & Johnson) · Observational
The primary objective of this prospective multicenter study is to assess whether 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 with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the functional outcome after conservative treatment.
Osteoarthritis (OA) of the knee (gonarthrosis) is a common medical condition and causes pain and disability. By 65 years of age, the majority of the US population has radiographic evidence of OA and 11% have symptomatic OA of the knee. In Japan, OA of the knee is more common due to the common sitting style with maximally flexed knees and parallel position of both legs.
High Tibial Osteotomy (HTO) for knee OA is a standard procedure in orthopedic surgery. Six years ago, HTO using TomoFix™ was introduced. Because Asian people have different geometric dimensions of the tibiae, an adaptation of size and shape was necessary, and the new TomoFix™ Small was developed. Although there is widespread literature concerning osteotomy for treating knee OA, literature assessing patient outcome after open wedge HTO using TomoFix™ is rare and for TomoFix™ Small, this data is still nonexistent. Therefore, the primary aim of the present multicenter study is to evaluate patient functional outcome using the KOOS. Since a proportion of patients with the indication for HTO refuse surgery and opt to receive conservative treatment, the functional results of patients treated with HTO using TomoFix™ Small will be compared with these patients.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 148 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted before Synthes GmbH became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Patients with Indication for open wedge HTO with the TomoFix™ Small presenting in the orthopaedic department of the participating hospitals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For conservative group only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical treatment using TomoFix TM Small
Other: No intervention
In the control group, patients who refused to have surgery will be allowed to be treated using different options of conservative treatment. The frequency of applications depends on the hospital and will therefore be documented in the study. An arthroscopy is not obligatory under this treatment group, but is permitted. The following conservative treatment methods are allowed: 1. Physical therapy 2. Specific exercises for the muscles 3. Injections into the knee joint 4. Brace 5. Medication 6. No therapy
Other: No intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Patient-evaluated function of the knee and quality of life, a. assessed with the Oxford-12-item knee score b. assessed with the WOMAC (as calculated from the KOOS)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Health-related quality of life assessed by the generic Short Form-36 (SF-36) instrument
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Range of motion (ROM)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Local and general pain, assessed with the Visual Analogue Scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Possibility and duration of the Japanese sitting style
Time frame: 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization
Time frame: postoperative period
Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino)
Time frame: intraoperative and after 2 years
Radiological parameters (e.g. union, delayed union, Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara, patella height according to Blackburne-Peel, modified Insall-Salvati ratio, subluxation of patella)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Complications and mortality
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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