Subacromial Balloon Spacer: Difference between revisions

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== Description<br>  ==
== Description ==
InSpace (Orthospace) biodegradable balloon system is also known as a subacromial balloon spacer. These spacers are composed of polylactide and e-caprolactone copolymer.<ref name=":0">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.'' </ref>The spacers are biodegradable and are believed to last 12 months or less.<ref name=":0" />Placement of these spacers is typicaly minimally invasive with low rates of complications. <ref name=":0" />
'''This article or area is currently under construction and may only be partially complete. Please come back soon to see the finished work!'''


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. <ref>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. </ref>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.
InSpace (Orthospace) biodegradable balloon system is also known as a subacromial balloon spacer. These spacers are composed of polylactide and ε-caprolactone copolymer.<ref name=":0">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.'' </ref>The spacers are biodegradable and are believed to last 12 months or less.<ref name=":0" />Placement of these spacers is typicaly minimally invasive with low rates of complications. <ref name=":0" />
 
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. <ref name=":1">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. </ref>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.<ref name=":0" />This device allows for improved biomechanics of the shoulder when the rotator cuff cannot be repaired.<ref name=":0" /> It reduces subacromial friction so that the humeral head is closer against the glenoid cavity.<ref name=":0" />
The surgical procedure of a subacromial balloon spacer is typically performed arthroscopically through the lateral shoulder.<ref name=":0" />This device allows for improved biomechanics of the shoulder when the rotator cuff cannot be repaired.<ref name=":0" /> It reduces subacromial friction so that the humeral head is closer against the glenoid cavity.<ref name=":0" />


== Indication<br>  ==
== Indication ==


Balloon spacers in the management of massive rotator cuff tears: a focus on clinical outcomes (Knapik)
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.<ref name=":1" /> Irreparable tears consist of tears that can not be repaired to a natural footprint, or if repaired it will retear.<ref name=":1" /> Common signs of irreparable tears includes fatty infilitation of 50% or more, static superior migration of the humeral head, and absent acromiohumeral interval.<ref name=":0" /> 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.<ref name=":1" />


* Massive rotator cuff tears involve >/= 5 cm or involving 2 or more tendons).  
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.<ref name=":1" /> 
* 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.
== Clinical Presentation  ==


* 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)
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.<ref name=":1" /> This restores the coupling forces between the subscapularis and teres minor, as well as improves the function of the deltoid.<ref name=":1" />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.<ref name=":1" />


* 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)
After surgery, the spacer remains inflated for 6-12 months.<ref name=":0" />,<ref name=":1" />This allows the retraining of the muscles around the shoulder joint to improve muscle balance and biomechanics.<ref name=":1" />


== Clinical Presentation  ==
Complication rates range from 2-16.7%.<ref name=":1" /> The most common complication is spacer migration.<ref name=":1" />The next surgical intervention is a reverse total shoulder arthroplasty.<ref name=":1" />
 
* 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  ==
== Diagnostic Tests  ==


add text here relating to diagnostic tests for the condition<br>
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  ==
== Pre-Op  ==


add text here relating to the pre-operative advice
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  ==
== Post-Op  ==
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.
Precautions after surgery typically include: immobilization for 4-6 weeks; no sudden movements, repetitive movements, or lifting for 3 months.<ref name=":2">Shoulder Balloon Implant Protocol. OrthoIllinois Rehabilitation, 2021.</ref>,<ref name=":3">Post-Operative Protocol for Patients Following InSpace Implantation. Ortho Space. 2022.</ref>
A general protocol is provided below. Always check with your referring surgeon on specifics for each individual patient.
'''Phase I (Day 0-4 weeks):'''
* Use of immobilizing sling<ref name=":2" />
* Modalities as needed<ref name=":2" />
* PROM, A/AROM exercises to stay within pain threshold. Shoulder should be limited to 0-60<sup>0</sup> <ref name=":2" />
* Pendulum exercises<ref name=":2" />


* No clear consensus has been reached regarding optimal management.
'''Phase II (4-6 weeks):'''
* 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.
* Decrease use of sling (use only for comfort).<ref name=":2" />
** Phase I (Day 1 - 4 weeks post-op)
* PROM/AROM to achieve full motion. <ref name=":2" />
*** Modalities PRN
* Driving can resume once the patient can safely use both hands on the steering wheel and is free from use of prescription pain medications that may impact driving abilities.<ref name=":3" />
*** Sling: worn continuously except for therapy or during exercise
 
*** ROM: all ROm must stay below pain threshold
'''Phase III (6-12 weeks):'''
**** 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*
* Temporary discomfort is normal at this phase. <ref name=":2" />
**** Pendulum exercises
* Continue progressing ROM and include strengthening. <ref name=":2" />
**** Gentle shoulder rotation may begin but must be controlled/pain-free
* Start to return to normal activity.<ref name=":2" />
** Phase III (4 weeks - 6 weeks)
 
*** Sling: removed at 4 weeks unless needed for comfort, while sleeping or during physical activity
'''Phase IV (12+ weeks)'''
*** ROM:
 
**** PROM/AROM to achieve functional ROM with slow steady stretching
* Rehabilitation may continue through 6 months post-op.<ref name=":2" />
**** 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 <br>  ==
== Resources <br>  ==


add appropriate resources here
Ortho Illinois Shoulder Balloon Implant Protocol: 
 
* https://www.orthoillinois.com/wp-content/uploads/2022/01/Shoulder-Balloon-Implant-Protocol-12-22-21.pdf<ref name=":2" />
 
Ortho Space Post-Operative Protocol for Patients Following InSpace<sup>TM</sup> implantation:
 
* https://www.nth.nhs.uk/content/uploads/2019/02/inspace-balloon-spacer-postop-protocol.pdf<ref name=":3" />


== References  ==
== References  ==


<references />
<references />

Latest revision as of 19:47, 28 November 2022


Original Editor - Jessica Galasso

Top Contributors - Jessica Galasso  

Description[edit | edit source]

This article or area is currently under construction and may only be partially complete. Please come back soon to see the finished work!

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[edit | edit source]

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.

Precautions after surgery typically include: immobilization for 4-6 weeks; no sudden movements, repetitive movements, or lifting for 3 months.[3],[4]

A general protocol is provided below. Always check with your referring surgeon on specifics for each individual patient.

Phase I (Day 0-4 weeks):

  • Use of immobilizing sling[3]
  • Modalities as needed[3]
  • PROM, A/AROM exercises to stay within pain threshold. Shoulder should be limited to 0-600 [3]
  • Pendulum exercises[3]


Phase II (4-6 weeks):

  • Decrease use of sling (use only for comfort).[3]
  • PROM/AROM to achieve full motion. [3]
  • Driving can resume once the patient can safely use both hands on the steering wheel and is free from use of prescription pain medications that may impact driving abilities.[4]

Phase III (6-12 weeks):

  • Temporary discomfort is normal at this phase. [3]
  • Continue progressing ROM and include strengthening. [3]
  • Start to return to normal activity.[3]

Phase IV (12+ weeks)

  • Rehabilitation may continue through 6 months post-op.[3]

Resources
[edit | edit source]

Ortho Illinois Shoulder Balloon Implant Protocol:

Ortho Space Post-Operative Protocol for Patients Following InSpaceTM implantation:

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.
  3. ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 Shoulder Balloon Implant Protocol. OrthoIllinois Rehabilitation, 2021.
  4. ↑ 4.0 4.1 4.2 Post-Operative Protocol for Patients Following InSpace Implantation. Ortho Space. 2022.
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