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

This study is currently recruiting participants.
Verified January 2013 by AO Clinical Investigation and Documentation
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01048710
First received: January 13, 2010
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Osteoarthritis, Knee
Osteonecrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

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 ]

Estimated Enrollment: 148
Study Start Date: July 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tomofix_small
Conservative treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048710

Contacts
Contact: Takeshi Sawaguchi, MD +81 (0) 76 422 1112 sawaguch@mxq.mesh.ne.jp

Locations
Japan
Toyama Municipal Hospital Recruiting
Toyama-city, Japan, 939-8511
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
  More Information

Publications:

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01048710     History of Changes
Other Study ID Numbers: Tomofix_small
Study First Received: January 13, 2010
Last Updated: January 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AO Clinical Investigation and Documentation:
Knee osteoarthritis
knee osteonecrosis
osteotomy

Additional relevant MeSH terms:
Osteoarthritis
Osteonecrosis
Osteoarthritis, Knee
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013