Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

NCT ID: NCT02077647

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-07-31

Brief 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.

Detailed 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.

Conditions

Osteoarthritis, Knee; Osteonecrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Conservative

Conservative treatment of osteoarthritis of the knee

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Faeh

Role: STUDY_DIRECTOR

AO Clinical Investigation and Documentation, Davos, Switzerland

Takeshi Sawaguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Toyama Municipal Hospital, Toyama-city, Japan

Locations

Nagasaki University

Nagasaki, , Japan

Osaka Koseinenkin Hospital

Osaka, , Japan

Hashiba Orthopaedic Clinic

Toyama, , Japan

Toyama Municipal Hospital

Toyama, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 19165468 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19111218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18367399 (View on PubMed)

Other Identifiers

FR_Tomofix

Identifier Type: -

Identifier Source: org_study_id