Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears

Senekovič, Vladimir; Poberaj, Boris; Kovačič, Ladislav; Mikek, Martin; Adar, Eliyahu; Dekel, Assaf

doi:10.1007/s00590-012-0981-4

Cited by 131 publications

(94 citation statements)

References 21 publications

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“…These balloons were designed for reducing radiation adverse effects in prostate cancer by prostate-rectum separation (up to 9 mm) or as a sub-acromial spacer in the treatment of massive irreparable rotator cuff tears (Fig. 14) [304][305][306]. Balloon's shape, mechanical and chemical properties were premeditated to withstand the different surrounding tissue stress following minimally invasive balloon deployment and in situ inflation, up to a desired period of time (weeksmonths) and then gradually biodegrade.…”

Section: Other Applicationsmentioning

confidence: 99%

“…The balloon's safety and efficacy was established in a mammalian model and they have maintained their performance along the study followed by biodegradation without toxicity [304,305]. Recently, clinical studies have evaluated the safety and efficacy of these balloons for long term performance (up to 3 years of post-implantation) and the results were found promising, no safety issues were raised [306][307][308]. This example represents a good model for PLA property optimization and device fabrication to fulfill medical need, starting with proper polymer composition, implant degradability-mechanical stability balancing and proper sterilization technique development.…”

Section: Other Applicationsmentioning

confidence: 99%

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Physical and mechanical properties of PLA, and their functions in widespread applications — A comprehensive review

Farah

Anderson

Langer

2016

Advanced Drug Delivery Reviews

2,262

1,486

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Available online xxxxPoly(lactic acid) (PLA), so far, is the most extensively researched and utilized biodegradable aliphatic polyester in human history. Due to its merits, PLA is a leading biomaterial for numerous applications in medicine as well as in industry replacing conventional petrochemical-based polymers. The main purpose of this review is to elaborate the mechanical and physical properties that affect its stability, processability, degradation, PLA-other polymers immiscibility, aging and recyclability, and therefore its potential suitability to fulfill specific application requirements. This review also summarizes variations in these properties during PLA processing (i.e. thermal degradation and recyclability), biodegradation, packaging and sterilization, and aging (i.e. weathering and hygrothermal). In addition, we discuss up-to-date strategies for PLA properties improvements including components and plasticizer blending, nucleation agent addition, and PLA modifications and nanoformulations. Incorporating better understanding of the role of these properties with available improvement strategies is the key for successful utilization of PLA and its copolymers/composites/blends to maximize their fit with worldwide application needs.© 2016 Elsevier B.V. All rights reserved. Contents lists available at ScienceDirectAdvanced Drug Delivery Reviews

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Section: Other Applicationsmentioning

confidence: 99%

Section: Other Applicationsmentioning

confidence: 99%

Physical and mechanical properties of PLA, and their functions in widespread applications — A comprehensive review

Farah

Anderson

Langer

2016

Advanced Drug Delivery Reviews

2,262

1,486

View full text Add to dashboard Cite

show abstract

“…This device, which is intended for arthroscopic or mini-open insertion in humans, has proven to treat shoulder pain and improve range of motion when implanted in patients with massive irreparable RC tears (Senekovic et al 2013). It is composed of a copolymer of poly-L-lactide-co-e-caprolactone (PLCL) in a 70:30 ratio and is a well-known poly(a-hydroxy acid; Levy et al 2009).…”

Section: Introductionmentioning

confidence: 99%

Long-term Local and Systemic Safety of Poly(l-lactide-co-epsilon-caprolactone) after Subcutaneous and Intra-articular Implantation in Rats

Ramot

Nyska

Markovitz³

et al. 2015

Toxicol Pathol

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The use of biodegradable materials is gaining popularity in medicine, especially in orthopedic applications. However, preclinical evaluation of biodegradable materials can be challenging, since they are located in close contact with host tissues and might be implanted for a long period of time. Evaluation of these compounds requires biodegradability and biocompatibility studies and meticulous pathology examination. We describe 2 preclinical studies performed on Sprague-Dawley rats for 52 weeks, to evaluate clinical pathology, biocompatibility, biodegradability, and systemic toxicity after implantation of 2-layered films or saline-inflated balloon-shaped implants of downsized InSpace™ devices (termed ''test device''). The test devices are made from a copolymer of poly-L-lactide-co-e-caprolactone in a 70:30 ratio, identical to the device used in humans, intended for the treatment of rotator cuff tears. Intra-articular film implantation and subcutaneous implantation of the downsized device showed favorable local and systemic tolerability. Although the implanted materials have no inherent toxic or tumorigenic properties, one animal developed a fibrosarcoma at the implantation site, an event that is associated with a rodent-predilection response where solid materials cause mesenchymal neoplasms. This effect is discussed in the context of biodegradable materials along with a detailed description of expected pathology for biodegradable materials in long-term rodent studies.

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“…9 The fluoroscopy-guided insertion of the InSpace spacer with patients under local anesthesia provides a simple, minimally invasive option for treatment of massive RCTs. Furthermore, the technique provides a low-risk, clinically effective option for an elderly patient population disabled by massive cuff tears but for whom surgery such as reverse arthroplasty is high risk because of multiple medical factors and comorbidities that significantly increase their risk when undergoing routine surgical procedures under general anesthesia.…”

Section: Discussionmentioning

confidence: 99%

Fluoroscopy-Guided Implantation of Subacromial “Biodegradable Spacer” Using Local Anesthesia in Patients With Irreparable Rotator Cuff Tear

Gervasi

Cautero

Dekel

2014

Arthroscopy Techniques

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Treatment of massive rotator cuff tears can be challenging, especially when tears are considered irreparable or, when repaired, at significant risk of retear. A surgical technique is described using a biodegradable subacromial balloonshaped spacer (InSpace; Ortho-Space, Caesarea, Israel) that, when implanted between the humeral head and acromion, permits smooth, frictionless gliding, supporting shoulder biomechanics. The specific insertion technique described herein is a simple procedure that can be performed in a day-care or outpatient setting with patients under local anesthesia, thus providing a treatment option for patients with multiple comorbidities complicating or contraindicating surgery, such as reverse arthroplasty under general anesthesia.

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Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears

Cited by 131 publications

References 21 publications

Physical and mechanical properties of PLA, and their functions in widespread applications — A comprehensive review

Physical and mechanical properties of PLA, and their functions in widespread applications — A comprehensive review

Long-term Local and Systemic Safety of Poly(l-lactide-co-epsilon-caprolactone) after Subcutaneous and Intra-articular Implantation in Rats

Fluoroscopy-Guided Implantation of Subacromial “Biodegradable Spacer” Using Local Anesthesia in Patients With Irreparable Rotator Cuff Tear

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