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

August 21, 2018 updated by: Synthes GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Toyama-city, Japan, 939-8511
        • Toyama Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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
  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tomofix_small
Surgical treatment using TomoFix TM Small
Other: No intervention
Conservative treatment

In 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
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Health-related quality of life assessed by the generic Short Form-36 (SF-36) instrument
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Range of motion (ROM)
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Local and general pain, assessed with the Visual Analogue Scale (VAS)
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Possibility and duration of the Japanese sitting style
Time Frame: 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization
Time Frame: postoperative period
postoperative period
Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino)
Time Frame: intraoperative and after 2 years
intraoperative and after 2 years
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)
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Complications and mortality
Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synthes GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson K.K. Medical Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Takeshi Sawaguchi, MD, Toyama Municipal Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tomofix_small

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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