Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears
| Autor: | Assaf Dekel, Vladimir Senekovic, Ladislav Kovacic, Eliyahu Adar, Boris Poberaj, Martin Mikek |
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| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Joint Prosthesis Balloon Rotator Cuff Injuries Shoulder Pain Absorbable Implants medicine Humans Orthopedics and Sports Medicine Rotator cuff Prospective Studies Arthroplasty Replacement Prospective cohort study Aged Aged 80 and over medicine.diagnostic_test business.industry Shoulder Joint Rotator cuff injury Arthroscopy Middle Aged medicine.disease Arthroplasty Surgery Clinical trial medicine.anatomical_structure Shoulder Impingement Syndrome Tears Female business Acromion |
| Zdroj: | European journal of orthopaedic surgerytraumatology : orthopedie traumatologie. 23(3) |
| ISSN: | 1432-1068 |
| Popis: | The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3 years post-implantation. Twenty patients were implanted with the InSpace™ device and assessed up to 3 years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events. Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2–20 min. The mean total Constant score increased from 33.4 to 65.4 points at 3 years. There was an improvement of 6.4 points in subjective pain score which commenced at 1 week post-operatively and was sustained until 3 years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18 months of follow-up but was sustained at 3 years. Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications. IV; therapeutic case series |
| Databáze: | OpenAIRE |
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