Overview

This trial is active, not recruiting.

Conditions osteoarthritis, knee, osteonecrosis
Sponsor AO Clinical Investigation and Documentation
Start date March 2014
End date April 2015
Trial size 20 participants
Trial identifier NCT02077647, FR_Tomofix

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Conservative treatment of osteoarthritis of the knee

Primary Outcomes

Measure
Function of the knee
time frame: 24 months

Secondary Outcomes

Measure
Patient-evaluated function of the knee and quality of life
time frame: 6 months, 12 months, 24 months
Clinician-evaluated function of the knee
time frame: 6 months, 12 months, 24 months
Health-related quality of life
time frame: 6 months, 12 months, 24 months
Range of motion (ROM)
time frame: 6 months, 12 months, 24 months
Local and general pain
time frame: 6 months, 12 months, 24 months
Possibility and duration of the Japanese sitting style
time frame: 6 months, 12 months, 24 months
Return to sport activities
time frame: 6 months, 12 months, 24 months
Utilization
time frame: up to hospital discharge
Evaluation of degenerated and regenerated cartilage
time frame: intraoperative and after 2 years
Radiological parameters
time frame: 6 months, 12 months, 24 months
Complications
time frame: 6 months, 12 months, 24 months
Anatomical alignment
time frame: 6 months, 12 months, 24 months

Eligibility Criteria

Male or female participants at least 40 years old.

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)

Additional Information

Official title A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee
Principal investigator Takeshi Sawaguchi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.