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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:

The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.

The incidence of knee osteoarthritis (OA) is higher in Japan than in other populations. Respective prevalences of 47.0 and 70.2% in men and women for Kellgren-Lawrence Grades 2-4 knee OA are reported in Japanese patients aged 60 years and over.

First treatment options are pharmacological (i.e. NSAIDs) and non-pharmacological therapies (i.e. use of assistive devices, exercises, osteopathy, physical therapy), followed by injections of hyaluronic acid and other substances. If no such therapies are successful, surgical treatment options as unicompartmental knee replacement, total knee arthroplasty and high tibial osteotomy (HTO) are recognized. The discussion of which is the best therapy is still controversial. HTO may decrease the number of complications compared to total knee replacement or unicompartmental knee arthroplasty and leave the option for later replacement surgery.

In this project, patients are included who would be surgically treated with HTO with Tomofix small based on the investigator's assessment but refuse to have surgical treatment. They will be treated conservatively and are investigated to serve as reference to an ongoing clinical study investigating invasive treatment modalities.


Recruitment information / eligibility

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)

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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