Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatment phantom system
Sponsor Moximed
Start date October 2014
End date October 2017
Trial size 40 participants
Trial identifier NCT02711254, KINE-1406

Summary

The purpose of this study is to evaluate improvement in pain and function following implantation of a new device, called the Phantom Knee System, in patients needing unloading of the medial compartment of the knee

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will be treated with the Phantom Knee System device
phantom system Phantom Knee System
Unloading of medial knee compartment with Phantom System

Primary Outcomes

Measure
Pain measured by the Pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: Baseline and 24 months
Change in function measured by the Function subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: Baseline and 24 months
Monitoring of adverse events
time frame: Baseline to 24 months

Secondary Outcomes

Measure
Procedural success
time frame: Intraoperative
Change in function measured by the Knee Society Score (KSS).
time frame: Baseline and 24 months
Radiographic integrity of device
time frame: Baseline to 24 months

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

Inclusion Criteria: 1. Male or female between 25 and 65 years of age, inclusive 2. Documented pathology of the medial compartment of the knee that requires unloading with 3. Tibial femoral varus alignment of ≤7⁰ as measured using mechanical axis on a long standing anterior-posterior (AP) view X-ray 4. Has continued target knee pain despite 6 months of conservative treatment prior to surgery 5. Has pain in the target knee as demonstrated by a minimum score of 40 (scale 0-100) on the KOOS pain domain questions 6. Knee flexion ≥90⁰ to ≤140⁰ 7. BMI 24-35 kg/m² 8. Weight ≤ 110 kg 9. Willing and able to give and have given voluntary written informed consent to participate in this clinical investigation 10. Prepared to consent to the transfer of his/her information to third parties 11. Willing to undertake the required investigational procedures and willing to return for the required follow-up evaluations Exclusion Criteria: 1. Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint. 2. Rheumatoid arthritis or other forms of inflammatory joint disease. 3. Significant OA in the lateral compartment of the study knee, defined as Kellgren-Lawrence grade of > 2 as assessed by the investigator using X-ray. 4. Significant OA in the patello-femoral compartment of the study knee, defined as Kellgren-Lawrence grade > 3 as assessed by the investigator using X-ray. 5. Contralateral knee has radiographic evidence of OA (KL grade>2) AND clinical findings of OA symptoms that interfere with activities of daily living or require the use of an assist device 6. Previous joint modifying surgery in the target knee within 12 months prior to planned surgery date such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture a) Arthroscopic surgeries for joint lavage, meniscectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date 7. Previous lateral meniscectomy >30% of the target knee 8. Previous patellar surgery in the target knee 9. Previous osteotomy or failed knee joint replacement in the target knee 10. Tibial-femoral valgus alignment >0⁰ as measured using mechanical axis on a long standing AP view x-ray 11. Tibial-femoral varus alignment >7⁰ as measured using mechanical axis on a long standing AP view X-ray 12. Hyperextension >5⁰ 13. Flexion deformity greater than 10⁰ 14. Ligamentous laxity, or meniscal instability as assessed by the investigator 15. Cruciate ligament instability with Lachman test, grade 2 or higher 16. Uncontrolled diabetes mellitus 17. Current smoker or stopped <1 year prior to enrollment 18. Known or suspected diagnosis of Osteoporosis 19. Paget's Disease of the bone 20. Other metabolic disorders that may impair bone formation (must specify in records) 21. Concomitant immunosuppressive therapy 22. Known or suspected diagnosis of Osteomalacia 23. Known or suspected diagnosis of Osteonecrosis 24. Infections which may spread to the implant site from distant foci 25. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray 26. Vascular insufficiency, muscular atrophy, neuromuscular disease 27. Any significant medical condition (e.g., cancer, HIV, chronic pain management for conditions such as neuropathic pain and fibromyalgia, significant psychiatric or neurological disorders, active alcohol/drug abuse, etc) or other factor (e.g. planned relocation, uncooperative patient) that the Investigator feels would interfere with study participation/completion 28. Pregnancy or lactation or planning to become pregnant 29. History of litigation for workers benefits for musculoskeletal injuries 30. Currently enrolled in another clinical investigation that may influence the follow-up or may confound the outcome of this study 31. Prisoners

Additional Information

Official title Feasibility of the Phantom Knee System in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: A Prospective, Multi-Center, Single-Arm First in Human Study
Principal investigator Willem van der Merwe
Description This is a prospective, multi-center, single-arm, first in human (FIH) study. Patients will be asked to participate in the study and follow up for a 6 month (Polish sites) or 24 month (South African site) period following implantation of the study device.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Moximed.