BION Treatment of Knee Osteoarthritis

BION Implantable Microstimulator System

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: BION

Detailed Description

Knee Osteoarthritis is a common problem with people over the age of 50 and is often debilitating because of the challenges it poses to normal walking function. Research has shown that exercise can lessen the effect of the osteoarthritis in the knee if done diligently. BION®s implanted in the thigh can produce contractions of the quadriceps muscles without much movement of the knee joint, an advantage if moving the knee is painful. In this study, teh subjects 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. All participants will be eligible to continue treatment following the initial 12 weeks if medically appropriate and resources permit.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
2. Subject is between 18 and 75 years old.
3. Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
4. Subject is mentally capable of understanding the goals and the application of therapy.
5. Subject is able to apply the therapy (with or without help) in the home setting.
6. Subject is willing and capable of giving informed consent.
7. Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.

Exclusion Criteria:

1. Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
2. Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
3. Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
4. Subject has a history of falling.
5. Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
6. Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
7. Subject has cancer.
8. Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
9. Subject has bilateral knee osteoarthritis.
10. Subject is taking pain medications with dosage not stable for one month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BION "twitch" stimulation; 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.	Device: BION; 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.
Experimental: BION tetanic-frequency stimulation; The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.	Device: BION; 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.
No Intervention: Standardized program; A third group of experimental subjects will have a standardized program of voluntary exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quadriceps isometric strength	pre-exercise, 4w, 8w, 12w

Secondary Outcome Measures

Outcome Measure	Time Frame
Gait velocity Gait endurance Pain WOMAC	pre-exercise, 8w, 12w

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Lucinda Baker, Ph.D, University of Southern California

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Neuromuscular stimulator
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BT5