None listed
Conditions
Brief summary
This is a 12 month study seeking to enroll patients with symptomatic knee pain caused by osteoarthritis, who are bowlegged (with varus malalignment). The study will evaluate the safety of a new implant designed to realign the lower leg. Realignment can prevent further progress of osteoarthritis, decrease pain and allow individuals to return to more normal activity. In order to evaluate the safety of the system the study will collect information on any problems patients may experience during the surgery and recovery (up to 12 months), X-rays of the leg to evaluate bone healing and stability of the implant, and answers to surveys with questions about how patients are feeling and what their activity level is. This information will then be compared to a matched group of patients who had a high tibial osteotomy performed with a currently available metal plate and screw system.
Interventions
All patients will have a high tibial osteotomy performed using the AKRFX System with the implant and anchors. The implant and anchors are intended to be permanent though they can be removed if necessary. Patients in the historical control group will have received osteotomy using currently available systems. No contact will be made with these patients. All information will be obtained from an existing database at the Fowler Kennedy Sports Medicine Clinic in London, Ontario Canada
Sponsors
iBalance Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Require 3-12 degrees of varus correction Localized pain in posterior-medial quadrant of knee Grades II, III, and IV medial compartment knee osteoarthritis (Kellgren-Lawrence Scale)
Exclusion criteria
1) Diabetes (any type or status) or any metabolic disorder or other condition which may impair bone formation (e.g. osteoporosis) 2) Inflammatory joint disease 3) Patients who, in the opinion of the investigator, have a medical condition that would preclude this patient from completing the study (e.g. concurrent chronic illness such as neuropathy, HIV, cancer or other terminal illness) 4) Previous reconstructive surgery that would prohibit use of the AKRFX system or compromise the AKRFX surgical technique 5) Previous lateral meniscectomy greater than 30% 6) Previous knee osteotomies in the study knee 7) Previous patellectomy 8) Gross tibial tubercle deformity 9) Cruciate ligament instability with Lachman Test, Grade 2 or higher 10) Posterior Draw Test, Grade 2 or higher 11) Evidence of Grade 3 or higher lateral compartment osteoarthritis (Kellgren Lawrence Scale) 12) Evidence of Grade 3 or higher patella osteoarthritis (Kellgren Lawrence Scale) 13) Proximal tibial width < 64 mm or > 88 mm 14) Current smoker or quit smoking less than one year ago 15) Body Mass Index over 35
Outcome results
None listed