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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048710
• Other study ID #: Tomofix_small
• Status: Completed
• Start date: July 1, 2009
• Est. completion date: May 7, 2018

Study information

• Verified date: August 2018
• Source: Synthes GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 7, 2018
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteonecrosis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Japan	Toyama Municipal Hospital	Toyama-city

Sponsors (2)

Lead Sponsor	Collaborator
Synthes GmbH	Johnson & Johnson K.K. Medical Company

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Range of motion (ROM)		1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Secondary	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
Secondary	Possibility and duration of the Japanese sitting style		3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Secondary	Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization		postoperative period
Secondary	Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino)		intraoperative and after 2 years
Secondary	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)		1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Secondary	Complications and mortality		1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years