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

NCT01048710 | Completed

• 1 other identifier: Tomofix_small
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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 the TomoFix™ Small is better than the functional outcome after conservative treatment.

Conditions

Osteoarthritis, Knee; Osteonecrosis

Keywords

Knee osteoarthritis; knee osteonecrosis; osteotomy

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

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

Secondary Outcomes (10)

• 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)

  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

  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

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

• Range of motion (ROM)

  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)

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

Study Arms (2)

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

Interventions

No intervention OTHER

Conservative treatment; Tomofix_small

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Synthes GmbH: lead
• Johnson & Johnson K.K. Medical Company: collaborator

Study Sites (1)

Toyama Municipal Hospital

Toyama, 939-8511, Japan

Location

Related Publications (3)

• 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.

  PMID: 19165468 BACKGROUND

• 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.

  PMID: 19111218 BACKGROUND

• 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.

  PMID: 18367399 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Takeshi Sawaguchi, MD

  Toyama Municipal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: July 1, 2009
• Primary Completion: March 31, 2015
• Study Completion: May 7, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

JP (1)