Clinical trial NCT01048710: Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively
Official title: Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Osteonecrosis
Keywords: Knee osteoarthritis
knee osteonecrosis
osteotomy
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson K.K. Medical Company
First posted: 2010-01-14
Enrollment: 148
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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)

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Secondary outcomes:
measure: 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)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Health-related quality of life assessed by the generic Short Form-36 (SF-36) instrument
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Range of motion (ROM)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Local and general pain, assessed with the Visual Analogue Scale (VAS)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Possibility and duration of the Japanese sitting style
timeFrame: 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization
timeFrame: postoperative period
measure: Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino)
timeFrame: intraoperative and after 2 years
measure: 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)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
measure: Complications and mortality
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years
Other outcomes:
Locations:
city: Toyama-city
country: Japan
facility: Toyama Municipal Hospital
Study officials:
affiliation: Toyama Municipal Hospital
name: Takeshi Sawaguchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.