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Osteoarthritis, KneeNCT02077647

Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

An observational study of Osteoarthritis, Knee and Osteonecrosis, run by AO Clinical Investigation and Publishing Documentation at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis, Knee, Osteonecrosis
How many people
20 participants
Where
4 sitesJapan
Study dates
Mar 2014to Jul 2019
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Nagasaki University

    Nagasaki, 852-8501

  • Osaka Koseinenkin Hospital

    Osaka, 553-0003

  • Hashiba Orthopaedic Clinic

    Toyama, 939-8055

  • Toyama Municipal Hospital

    Toyama, 939-8511

Other trials in Japan

About this study

Official title: A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

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.

Read the 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.

Keywords
Knee osteoarthritis, knee osteonecrosis, osteotomy
Medical subject headings
Osteoarthritis, Knee, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02077647
Study groupRoleWhat they receive
ConservativeConservative treatment of osteoarthritis of the knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Function of the knee

    Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Measured: 24 months

Secondary outcomes (12)

  1. Patient-evaluated function of the knee and quality of life

    Oxford-12-item knee score, WOMAC (as calculated from the KOOS)

    Measured: 6 months, 12 months, 24 months

  2. Clinician-evaluated function of the knee

    Japanese Orthopaedic Association (JOA) score

    Measured: 6 months, 12 months, 24 months

  3. Health-related quality of life

    Short Form-36 (SF-36)

    Measured: 6 months, 12 months, 24 months

  4. Range of motion (ROM)

    Measured: 6 months, 12 months, 24 months

  5. Local and general pain

    Visual Analogue Scale (VAS)

    Measured: 6 months, 12 months, 24 months

  6. Possibility and duration of the Japanese sitting style

    Measured: 6 months, 12 months, 24 months

  7. Return to sport activities

    Measured: 6 months, 12 months, 24 months

  8. Utilization

    Length of hospital stay

    Measured: up to hospital discharge

  9. Evaluation of degenerated and regenerated cartilage

    ICRS and Outerbridge / Koshino)

    Measured: intraoperative and after 2 years

  10. Radiological parameters

    Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara

    Measured: 6 months, 12 months, 24 months

  11. Complications

    Complications due to injections, complications due to heat therapy, complications due to medication (NSAIDs)

    Measured: 6 months, 12 months, 24 months

  12. Anatomical alignment

    Femoro tibial angle (FTA)

    Measured: 6 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2015
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
20 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077647
Sponsor's protocol ID
FR_Tomofix
Status last verified
Aug 2020
First submitted
12 Feb 2014
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19165468

  • 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.

    PubMed 19111218

  • 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.

    PubMed 18367399

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee and Osteonecrosis, run by AO Clinical Investigation and Publishing Documentation at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Function of the knee (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077647, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.

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