NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: Synthes GmbH

Conditions: Osteoarthritis, Knee, Osteonecrosis

Interventions: No intervention

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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)

Locations (1)

Toyama, Japan