Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT02077647
First received: February 12, 2014
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

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.


Condition
Osteoarthritis, Knee
Osteonecrosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Function of the knee [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Knee Injury and Osteoarthritis Outcome Score (KOOS)


Secondary Outcome Measures:
  • Patient-evaluated function of the knee and quality of life [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Oxford-12-item knee score, WOMAC (as calculated from the KOOS)

  • Clinician-evaluated function of the knee [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Japanese Orthopaedic Association (JOA) score

  • Health-related quality of life [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Short Form-36 (SF-36)

  • Range of motion (ROM) [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Local and general pain [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Visual Analogue Scale (VAS)

  • Possibility and duration of the Japanese sitting style [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Return to sport activities [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Utilization [ Time Frame: up to hospital discharge ] [ Designated as safety issue: No ]
    Length of hospital stay

  • Evaluation of degenerated and regenerated cartilage [ Time Frame: intraoperative and after 2 years ] [ Designated as safety issue: No ]
    ICRS and Outerbridge / Koshino)

  • Radiological parameters [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara

  • Complications [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Complications due to injections, complications due to heat therapy, complications due to medication (NSAIDs)

  • Anatomical alignment [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Femoro tibial angle (FTA)


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: February 2017
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Conservative
Conservative treatment of osteoarthritis of the knee

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.

  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
  • 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

Exclusion Criteria:

  • 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
  • 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)
  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 ClinicalTrials.gov identifier: NCT02077647

Locations
Japan
Nagasaki University
Nagasaki city, Japan, 852-8501
Osaka Koseinenkin Hospital
Osaka, Japan, 553-0003
Hashiba Orthopaedic Clinic
Toyama-city, Japan, 939-8055
Toyama Municipal Hospital
Toyama-city, Japan, 939-8511
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Study Director: Andreas Faeh AO Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Takeshi Sawaguchi, MD Toyama Municipal Hospital, Toyama-city, Japan
  More Information

Publications:
Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02077647     History of Changes
Other Study ID Numbers: FR_Tomofix
Study First Received: February 12, 2014
Last Updated: May 21, 2015
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
Osteoarthritis, Knee
Osteonecrosis
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 30, 2015