Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

NCT02077647 | Completed

• 1 other identifier: FR_Tomofix
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis, Knee; Osteonecrosis

Keywords

Knee osteoarthritis; knee osteonecrosis; osteotomy

Outcome Measures

Primary Outcomes (1)

• Function of the knee

  Knee Injury and Osteoarthritis Outcome Score (KOOS)

  24 months

Secondary Outcomes (12)

• Patient-evaluated function of the knee and quality of life

  6 months, 12 months, 24 months

• Clinician-evaluated function of the knee

  6 months, 12 months, 24 months

• Health-related quality of life

  6 months, 12 months, 24 months

• Range of motion (ROM)

  6 months, 12 months, 24 months

• Local and general pain

  6 months, 12 months, 24 months

Study Arms (1)

Conservative

Conservative treatment of osteoarthritis of the knee

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Indication for open wedge HTO with the TomoFix™ Small presenting in the orthopaedic department of the participating hospitals

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (4)

Nagasaki University

Nagasaki, 852-8501, Japan

Location

Osaka Koseinenkin Hospital

Osaka, 553-0003, Japan

Location

Hashiba Orthopaedic Clinic

Toyama, 939-8055, Japan

Location

Toyama Municipal Hospital

Toyama, 939-8511, Japan

Location

Related 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.

  PMID: 19165468 BACKGROUND

• 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.

  PMID: 19111218 BACKGROUND

• 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.

  PMID: 18367399 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Faeh

  AO Clinical Investigation and Documentation, Davos, Switzerland

  STUDY DIRECTOR

• Takeshi Sawaguchi, MD

  Toyama Municipal Hospital, Toyama-city, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2019
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

JP (4)