Safety Study of the iBalance Axial Knee Realignment System (AKRFX)

Active, not recruiting

• Conditions: Osteoarthritis of the knee; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12607000422426
• Lead Sponsor: iBalance Medical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of expected and unexpected adverse events (e.g. infection, deep vein thrombosis, delayed union, lateral cortex fractures, collapse of the osteotomy)[From procedure to 12 months post-operation with evaluations at 6 weeks, 3 months, 6 months and 12 months post-operation.];Bone healing as measured by patients' ability to withstand full weightbearing without crutches and show no clinical signs of non-union or delayed union[From procedure to 12 months post-operation with evaluations at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-operation.]

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the SF-36 and KOOS Knee Survey[Pre-operation baseline and then 3 months, 6 months and 12 months post-operation];Radiographic evidence of non-union or delayed union including complications such as radiolucency around the implant resorption within the osteotomy, or collapse of the osteotomy as measured by the evaluation of anteroposterior (A/P) knee X-rays[Post-operation baseline and at 6 weeks, 3 months, 6 months and 12 months post-operation];Stability of the implant in the bone evaluated by measurement of the osteotomy angle in A/P knee X-rays[Post-operation baseline, 6 weeks, 3 months, 6 months and 12 months post-operation.]