Dynamic Splinting Devices:

Aetna considers dynamic splinting devices for the knee, elbow, wrist or finger medically necessary durable medical equipment (DME) if either of the following two selection criteria is met:

1. As an adjunct to physical therapy in members with documented signs and symptoms of significant motion stiffness/loss in the sub-acute injury or post-operative period (i.e., at least 3 weeks after injury or surgery); or
2. In the acute post-operative period for members who have a prior documented history of motion stiffness/loss in a joint and are having additional surgery or procedures done to improve motion to that joint.

Aetna considers the prophylactic use of dynamic splinting experimental and investigational in the management of chronic contractures (no significant change in motion for a 4-month period) and joint stiffness due to joint trauma, fractures, burns, head and spinal cord injuries, rheumatoid arthritis, multiple sclerosis, muscular dystrophy or cerebral palsy. However, if surgery is being performed for a “chronic” condition, the use of a dynamic splinting system may be considered medically necessary if the member meets the selection criteria stated above.

Aetna considers the use of dynamic splinting experimental and investigational in the management of joint injuries of the shoulder, ankle and toe and for all other indications because there is a lack of scientific evidence regarding its effectiveness for these indications.

Flexionators and Extensionators:

Aetna considers the knee/ankle flexionator, the shoulder flexionator, the knee extensionator, and the elbow extensionator experimental and investigational because of a lack of scientific evidence of the effectiveness of these devices.

Joint Active Systems (JAS) Splints:

Aetna considers JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) experimental and investigational because there is insufficient evidence in the peer-reviewed published medical literature concerning their effectiveness.

Dynamic Splinting Systems:

Dynamic splinting systems are spring-loaded, adjustable devices designed to provide low-load prolonged stretch while patients are asleep or at rest. Dynamic splinting units (for both extension as well as flexion) are available for elbow, wrist, fingers, knee, ankle and toes. These units are being marketed for the treatment of joint stiffness due to immobilization or limited range of motion (ROM) as a consequence of fractures, dislocations, tendon and ligament repairs, joint arthroplasties, total knee replacements, burns, rheumatoid arthritis, hemophilia, tendon releases, head trauma, spinal cord injuries, cerebral palsy, multiple sclerosis, and other traumatic and non-traumatic disorders.

Dynamic splinting is commonly used in the post-operative period for the prevention or treatment of motion stiffness/loss in the knee, elbow, wrist or finger. It is not generally used in other joints such as the hip, ankle or foot.

Product names commonly encountered on the market for dynamic splinting include: Dynasplint™, Ultraflex™, LMB Pro-glide™, EMPI Advance™ and SaeboFlex™.

The SaeboFlex has been promoted for use in rehabilitation in persons with hemiplegia post cerebrovascular accident. However, there is no peer-reviewed published medical literature of the effectiveness of the device for this indication.

Flexionators and Extensionators:

The shoulder flexionator (ERMI Shoulder Flexionater®) is designed to isolate and treat decreased glenohumeral abduction and external rotation. The device is intended to addresses the needs of patients with excessive scar tissue. This customizable device has biomechanically and anatomically located pads to focus treatment on the glenohumeral joint, without stressing the other shoulder joints. Once customized, the shoulder flexionator can be used by the patient at home without assistance to perform serial stretching exercises, alternately stretching and relaxing the scar tissue surrounding the glenohumeral joint. The device has three sections, the main frame, arm unit and pump unit. The shoulder flexionator was listed with the FDA in 2001, and is Class I exempt.

The knee/ankle flexionator (ERMI Knee/Ankle Flexionater®) is a self-contained device that facilitates recovery from decreased range of motion of the knee and/or ankle joints. The knee flexionator is designed to address the needs of patients with arthrofibrosis (excessive scar tissue within and around a joint). The knee/ankle flexionator is a variable load/variable position device that uses a hydraulic pump and quick-release mechanism to allow patients to perform dynamic stretching exercises in the home without assistance, alternately stretching and relaxing the scar tissue surrounding affected joints. The knee/ankle flexionator includes a frame to house hydraulic components, a pump handle and quick release valve for patient control, supporting footplate and specially incorporated padded chair. The frame attaches to a folding chair and is adjustable to accommodate treatment of either extremity, or both extremities simultaneously. The load potential ranges from a few ounces up to 500 foot-pounds. The knee/ankle flexionator was listed with the FDA in 2002, and is Class 1 exempt.

The knee extensionator (ERMI Knee Extensionater®) and elbow extensionator (ERMI Shoulder Extensionater®) provide serial stretching, using a patient-controlled pneumatic device that can deliver variable loads to the affected joint. The manufacturer claims that the knee and shoulder extensionators are the only devices on the market that can “consistently stretch scar tissue, without causing vascular re-injury and thereby significantly reduce the need for additional surgery” (ERMI, 2002). The extensionator telescopes to the appropriate length, and is applied to the leg with Velcro straps. During a typical training session, the joint is stretched from 1 to 5 minutes, and then is allowed to recover for an equal length of time, and is then stretched again. A typical training session lasts 15 minutes, and the usual prescription is to perform 4 to 8 training sessions per day. There are no controlled published peer-reviewed studies on the effectiveness of the knee/ankle flexionator, the shoulder flexionator, the knee extensionator, or the elbow extensionator. There is insufficient scientific evidence to support the manufacturer's claims that these home-based stretching devices can consistently stretch scar tissues without causing vascular re-injury and thus significantly reduce the need for additional surgery (e.g., surgery for arthrofibrosis after knee surgery). Furthermore, there is a lack of published data to support the claim that these devices can reduce the need for surgery manipulation under anesthesia. Therefore, extensionator and flexionator devices are considered experimental and investigational.

Joint Active Systems (JAS) Splints:

JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) (Joint Active Systems, Effingham, IL) use static progressive stretch. According to the manufacturer's website, "Static Progressive Stretch (SPS) and dynamic splinting are two fundamentally different techniques used to permanently lengthen shortened connective tissues." Typically, the patient sets the device angle at the beginning of the session, and every several minutes the angle is increased. A typical session lasts 30 minutes, and sessions may be repeated up to three times per day. Unlike the flexionator, the joint is not allowed to recover during the stretch period. According to the manufacturer, JAS systems are designed to simulate manual therapy. The manufacturer claims that JAS devices eliminate the risk of joint compression, provide soft tissue distraction, and “achieve permanent soft tissue lengthening in a short amount of time.” Published reports of the effectiveness of JAS splints are limited to case reports and small uncontrolled case series. There are no prospective randomized studies demonstrating that the addition of the use of JAS devices to the physical therapy management of patients with joint injury or surgery significantly improves patient's clinical outcomes. Thus, JAS splints are considered experimental and investigational.