BION Treatment of Knee Osteoarthritis
BION Implantable Microstimulator System
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Osteoarthritic changes in the knee are a common cause of pain that restricts the subject's ability to move and may lead to surgical intervention with total knee replacement. Quadriceps muscle strengthening has been shown to improve the dynamic stability of the knee, decreasing pain during locomotion and increasing knee function. However, the gains associated with improved quadriceps strength have been difficult to achieve on a routine clinical basis because the currently available ways to increase muscle strength- through voluntary exercise or surface electrical stimulation- have significant practical problems that limit their use. The aim of this prospective study is to evaluate the safety and effectiveness of neuromuscular stimulation using implantable microstimulators called BIONs to improve the strength, range of motion, and health of the knee in patients with knee osteoarthritis. This investigation is expected to last 12 weeks for each study participant; the trial will be completed over a 3-year period. Patients recruited into the study will have advanced knee osteoarthritis for which total knee replacement surgery is being considered. The proposed study extends a feasibility study carried out in Milan, Italy on five patients with knee osteoarthritis, who were implanted with BIONs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 3, 2015
June 1, 2015
8 months
May 29, 2008
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quadriceps isometric strength
pre-exercise, 4w, 8w, 12w
Secondary Outcomes (1)
Gait velocity Gait endurance Pain WOMAC
pre-exercise, 8w, 12w
Study Arms (3)
BION "twitch" stimulation
EXPERIMENTALThe first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation.
BION tetanic-frequency stimulation
EXPERIMENTALThe second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.
Standardized program
NO INTERVENTIONA third group of experimental subjects will have a standardized program of voluntary exercise.
Interventions
They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises.
Eligibility Criteria
You may qualify if:
- Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
- Subject is between 18 and 75 years old.
- Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) in the home setting.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.
You may not qualify if:
- Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
- Subject has a history of falling.
- Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
- Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
- Subject has cancer.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
- Subject has bilateral knee osteoarthritis.
- Subject is taking pain medications with dosage not stable for one month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USC University Hospital
Los Angeles, California, 90033, United States
Related Publications (1)
Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. doi: 10.3171/foc.2006.20.5.3.
PMID: 16711659BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucinda Baker, Ph.D
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 3, 2015
Record last verified: 2015-06