Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Johnson & Johnson K.K. Medical Company
Information provided by (Responsible Party):
Synthes GmbH Identifier:
First received: January 13, 2010
Last updated: February 11, 2016
Last verified: February 2016
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.

Osteoarthritis, Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively

Resource links provided by NLM:

Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Range of motion (ROM) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization [ Time Frame: postoperative period ] [ Designated as safety issue: No ]
  • Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino) [ Time Frame: intraoperative and after 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Complications and mortality [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: July 2009
Estimated Study Completion Date: July 2018
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Surgical treatment using TomoFix TM Small
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

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.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01048710

Toyama Municipal Hospital
Toyama-city, Japan, 939-8511
Sponsors and Collaborators
Synthes GmbH
Johnson & Johnson K.K. Medical Company
Principal Investigator: Takeshi Sawaguchi, MD Toyama Municipal Hospital
  More Information

Responsible Party: Synthes GmbH Identifier: NCT01048710     History of Changes
Other Study ID Numbers: Tomofix_small 
Study First Received: January 13, 2010
Last Updated: February 11, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Synthes GmbH:
Knee osteoarthritis
knee osteonecrosis

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Pathologic Processes processed this record on January 18, 2017