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Osteoarthritis, KneeNCT01048710

Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively

An observational study of Osteoarthritis, Knee and Osteonecrosis, run by Synthes GmbH at 1 site 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 prospective multicenter study is to assess whether 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 with open wedge high tibial osteotomy (HTO) using… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis, Knee, Osteonecrosis
Type of treatment
Injection or infusion
How many people
148 participants
Where
1 siteJapan
Study dates
1 Jul 2009to 7 May 2018
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
  • Signed written informed consent (by the subjects or legal guardian) and agreement to attend all planned follow-ups
  • Willing and able to comply with the postoperative management program
  • Able to understand and read country national language at an elementary level

Who cannot join

  • Femoro-tibial angle (FTA) > 185o (standing view x-ray)
  • Flexion contracture > 15o
  • 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 14Show 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
  • For conservative group only:
  • HTO on the contralateral side
  • Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed)

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Toyama Municipal Hospital

    Toyama, 939-8511

Other trials in Japan

About this study

Official title: Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively

The primary objective of this prospective multicenter study is to assess whether 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 with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the functional outcome after conservative treatment.

Read the detailed description

Osteoarthritis (OA) of the knee (gonarthrosis) is a common medical condition and causes pain and disability. By 65 years of age, the majority of the US population has radiographic evidence of OA and 11% have symptomatic OA of the knee. In Japan, OA of the knee is more common due to the common sitting style with maximally flexed knees and parallel position of both legs.

High Tibial Osteotomy (HTO) for knee OA is a standard procedure in orthopedic surgery. Six years ago, HTO using TomoFix™ was introduced. Because Asian people have different geometric dimensions of the tibiae, an adaptation of size and shape was necessary, and the new TomoFix™ Small was developed. Although there is widespread literature concerning osteotomy for treating knee OA, literature assessing patient outcome after open wedge HTO using TomoFix™ is rare and for TomoFix™ Small, this data is still nonexistent. Therefore, the primary aim of the present multicenter study is to evaluate patient functional outcome using the KOOS. Since a proportion of patients with the indication for HTO refuse surgery and opt to receive conservative treatment, the functional results of patients treated with HTO using TomoFix™ Small will be compared with these patients.

Being tested
No intervention
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.

  • No interventionOther

Study groups in NCT01048710
Study groupRoleWhat they receive
Tomofix_smallSurgical treatment using TomoFix TM Small
Receives: Other: No intervention
Conservative treatmentIn the control group, patients who refused to have surgery will be allowed to be treated using different options of conservative treatment. The frequency of applications depends on the hospital and will therefore be documented in the study. An arthroscopy is not obligatory under this treatment group, but is permitted. The following conservative treatment methods are allowed: 1. Physical therapy 2. Specific exercises for the muscles 3. Injections into the knee joint 4. Brace 5. Medication 6. No therapy
Receives: Other: No intervention

What is being measured

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

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

Secondary outcomes (10)

  1. Patient-evaluated function of the knee and quality of life, a. assessed with the Oxford-12-item knee score b. assessed with the WOMAC (as calculated from the KOOS)

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  2. Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  3. Health-related quality of life assessed by the generic Short Form-36 (SF-36) instrument

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  4. Range of motion (ROM)

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  5. Local and general pain, assessed with the Visual Analogue Scale (VAS)

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  6. Possibility and duration of the Japanese sitting style

    Measured: 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  7. Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization

    Measured: postoperative period

  8. Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino)

    Measured: intraoperative and after 2 years

  9. Radiological parameters (e.g. union, delayed union, Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara, patella height according to Blackburne-Peel, modified Insall-Salvati ratio, subluxation of patella)

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

  10. Complications and mortality

    Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

Timeline

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

  1. First posted14 Jan 2010 (estimated)
  2. Study start1 Jul 2009
  3. Primary completion31 Mar 2015
  4. Study completion7 May 2018

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
Cohort
Time perspective
Prospective
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01048710
Sponsor's protocol ID
Tomofix_small
Status last verified
Aug 2018
First submitted
13 Jan 2010
Last updated
22 Aug 2018
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 Synthes GmbH at 1 site 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 7 inclusion and 14 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years). 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 NCT01048710, 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 22 Aug 2018.

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