Subacromial Balloon Spacer


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Description
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InSpace (Orthospace) biodegradable balloon system is also known as a subacromial balloon spacer. These spacers are composed of polylactide and ε-caprolactone copolymer.[1]The spacers are biodegradable and are believed to last 12 months or less.[1]Placement of these spacers is typicaly minimally invasive with low rates of complications. [1]

Subacromial balloon spacer are used for massive rotator cuff tears. Other typical intervention for massive rotator cuff tears are partial tendon repairs, subacromial decompression, bicep tenodesis, and reverse total shoulder arthroplasty. [2]There is no gold standard to treatment at this time. The selection of treatment depends on a multitude of factors including the patient's age, medical history, and condition of the shoulder.

The surgical procedure of a subacromial balloon spacer is typically performed arthroscopically through the lateral shoulder.[1]This device allows for improved biomechanics of the shoulder when the rotator cuff cannot be repaired.[1] It reduces subacromial friction so that the humeral head is closer against the glenoid cavity.[1]

Indication
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Subacromial balloon spacers can be indicated for massive rotator cuff tears or irreparable tears. A massive rotator cuff tear is considered a tear ≥5 cm or involving 2 or more tendons.[2] Irreparable tears consist of tears that can not be repaired to a natural footprint, or if repaired it will retear.[2] Common signs of irreparable tears includes fatty infilitation of 50% or more, static superior migration of the humeral head, and absent acromiohumeral interval.[1] The subacromial balloon spacer can also be used in younger patients to allow for additional time before a more radical procedure is performed, like shoulder arthroplasty.[2]

It is important to select appropriate patients when considering a subacromial balloon spacer. Individuals with glenohumeral arthritis, irreparable subscapularis tears, patients with infections, and those with allergies to the device materials.[2]

Clinical Presentation[edit | edit source]

The subacromial balloon spacer functions to restore normal biomechanics to the shoulder. The spacer depresses the humeral head so that it has a more centralized position in the glenoid cavity.[2] This restores the coupling forces between the subscapularis and teres minor, as well as improves the function of the deltoid.[2]This improves abduction and pain-relief by reducing impignement. The balloon spacer also reduces friction, redistributes forces, and facilitates smooth gliding of the humeral head.[2]

After surgery, the spacer remains inflated for 6-12 months.[1],[2]This allows the retraining of the muscles around the shoulder joint to improve muscle balance and biomechanics.[2]

Complication rates range from 2-16.7%.[2] The most common complication is spacer migration.[2]The next surgical intervention is a reverse total shoulder arthroplasty.[2]

Diagnostic Tests[edit | edit source]

MRI and X-rays are typically used to determine diagnosis and extent of shoulder damage. This will lead to determining what the appropriate intervention is for the patient.

Pre-Op[edit | edit source]

Patients typically go through a variety of conservative treatments prior to discussing surgical intervention. Patients will usually be treated by a physical therapist to improve ROM, stability, and strength of the shoulder. Patients may also undergo injections and other treatments. Once these interventions have failed, then the patient will undergo a surgical consult to discuss what the best course of action is for that individual patient.

Post-Op[edit | edit source]

There is currently no clear standard for a rehabilitation protocol for optimal management of a post-operative subacromial balloon spacer. The physical therapist should always discuss surgical precautions with the referring physician. Typical surgical protocols include use of a sling for 4-6 weeks.

  • No clear consensus has been reached regarding optimal management.
  • OrthoIllinois Rehabilitation Shoulder Balloon Implant Protocol
    • precautions: avoid quick sudden movements, repetitive movements, lifting of any weight or any activity that requires force or power to avoid movement of the balloon until 3 months post-op.
    • Phase I (Day 1 - 4 weeks post-op)
      • Modalities PRN
      • Sling: worn continuously except for therapy or during exercise
      • ROM: all ROm must stay below pain threshold
        • PROM, A/AROM may begin to tolerance/within protocol limits also including scapular mobility, cervical spine, elbow, forearm, wrist and hand exercises with grip.
        • Flexion and abduction: 0-60*
        • Pendulum exercises
        • Gentle shoulder rotation may begin but must be controlled/pain-free
    • Phase III (4 weeks - 6 weeks)
      • Sling: removed at 4 weeks unless needed for comfort, while sleeping or during physical activity
      • ROM:
        • PROM/AROM to achieve functional ROM with slow steady stretching
        • Activities may be completed independently or with therapist assistance
    • Phase IV (6 weeks - 12 weeks post-op)
      • Symptoms: it is normal to feel temporary discomfort or transient increase in shoulder pain a this stage.
      • ROM: gradually regain their preoperative ROM or steady progression on weekly basis including ROM/strength until return to normal activity
    • Phase V (12+ weeks post-op)
      • Rehab may continue through 6 months post-op to return to normal activity level or preoperative status. OrthoSpace Protocol:
    • immobilization 4-6 weeks
    • Avoid: quick sudden movements, repetitive movements, lifting of any weight and avoiding activity that requires force or power.
    • Driving is not recommended until such time as the patient can safely get both hands on the steering wheel and operate the vehicle safely.

Resources
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References[edit | edit source]

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 Stewart RK, Kaplin L, Parada SA, Graves BR, Verma NN, Waterman BR. Outcomes of subacromial balloon spacer implantation for massive and irreparable rotator cuff tears. Orthop. J. Sports Med.7(10), 2325967119875717. DOI: 10.1177/2325967119875717. 1-10.
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 Knapik DM, Williams BT, Verma NN. Balloon spacers in the management of massive rotator cuff tears: a focus on clinical outcomes. Ann Joint. 2021;6:19. dx.doi.org/10.21037/aoj-20-35. 1-10.