Subacromial Balloon Spacer

Original Editor - Jessica Galasso

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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 e-caprolactone copolymer.The spacers are biodegradable and are believed to last 12 months or less.Placement of these spacers is typicaly minimally invasive with low rates of complications.

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. 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.This device allows for improved biomechanics of the shoulder when the rotator cuff cannot be repaired. It reduces subacromial friction so that the humeral head is closer against the glenoid cavity.

Indication

Balloon spacers in the management of massive rotator cuff tears: a focus on clinical outcomes (Knapik)

• Massive rotator cuff tears involve >/= 5 cm or involving 2 or more tendons).
• Irreparable tears are defined as tears in which direct repair back to the native footprint is not feasible even with soft tissue mobilization and release, or tears deemed certain to retear despite repair.
  • Additional indicators include static superior migration of the humeral head, a narrowed or absent acromiohumeral interval, and fatty infiltration affecting greater than 50% of the rotator cuff musculature.

• The balloon spacer can be used as a bridging option for future procedures such as superior capsular reconstruction, tendon transfer, or shoulder arthroplasty in younger, active patients, or as a definitive procedure in patients medically unfit for extended surgical procedures.

• Appropriate selection is critical and should be avoided in patients with significant glenohumeral arthritis, irreparable subscapularis tears, as well as patients with active or latent infections and those allergic to device materials. (Knapik)

• Signs of irreparability include fatty infiltration affecting 50% or more of the rotator cuff musculature, static superior migration of the humeral head, and a narrowed or absent acromiohumeral interval on an upright anteroposterior shoulder radiograph. (steward)

Clinical Presentation

• Function: (Knapik)
  • OrthoSpace InSpace implant:
    • Biodegradable balloon-spacer made of a copolymer Poly.
    • Inserted into the subacromial space, typically arthroscopically.
    • Functions in cuff-deficient shoulders to restore native biomechanics by depressing the humeral head into a more centralized position on the glenoid. By restoring the coupling forces of the subscapularis and trees minor, and improving muscle contraction capacity with elongation of the deltoid, the spacer allows for improved abduction and pain relief by increasing shoulder ROM before impingement.
      • The subacromial balloon spacer significantly depressed the humor head at 0*, 30*, and 60* of abduction compared to the irreparable, cuff-deficit state.
      • Significantly increased the deltoid load at 0*, 30*, and 60* of abduction, while restoring glenohumeral contact pressures close to that of an intact rotator cuff state.
      • Balloon implantation has also been suggested to reduce the friction forces between the acromion and the humeral head, redistributing forces at the subacromial level, and facilitating smooth gliding of the humeral head under the acromion. This benefit has been examined int he context of balloon spacer plantation following partial rotator cuff repair.
      • Following implantation, the balloon spacer is estimated to remain inflated for approximately 6-12 months, after which time the spacer proceeds to degrade. This allows the patients to complete rehabilitation protocols for any arthroscopic procedure performed.
      • Sustained results beyond 12 months despite balloon degradation are attributed to more effective strengthening during the rehabilitation period secondary to effective restoration of muscle balance and patterning from reentering of the humeral head.

• Clinical: (Knapik)
  • Clinical studies are limited to small and short-term prospective trials; however, outcomes following spacer implantation are promising, including immediate postoperative improvements in various pain scores and validated functional outcomes that are often maintained or further improved at subsequent follow-up timepoints ranging from 2-5 years.
• Complications/Limitations: (Knapik)
  • Rate of 3-16.7%
  • Most common complications:
    • Spacer migration
  • Some switched to RTSA
  • Ideal patients: massive and irreparable rotator cuff tears with an intact or reparable subscapularis and restricted ROM secondary to pain. Spacer placement is not recommended in patients with irreparable subscapularis tears, as high speaker inflation volumes hav e been shown to result in anterior spacer translation in the presence of subscapularis insufficiency.

Diagnostic Tests

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Pre-Op

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Post-Op

• 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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