BACKGROUND: To investigate whether arthroscopic partial repair with the additional use of a biodegradable subacromial spacer would be proven better treatment for irreparable massive rotator cuff tears (MRCT) compared to single arthroscopic partial repair. METHODS: A matched-pairs case-control study of 32 patients suffering from irreparable MRCT who underwent an arthroscopic partial repair with (Group B: 16 patients) or without (Group A: 16 patients) InSpace Balloon (ISB®; Orthospace, Caesarea, Israel) implantation was conducted. For the clinical and functional assessment of the patients, the visual analog scale, Constant score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Range of Motion (RoM), and patients' satisfaction were obtained. RESULTS: The two groups were matched in all baseline demographic and clinical characteristics (n.s.). All mean final quantitative postoperative clinical and functional scores of group A (partial repair and ISB) and group B (single partial repair), as well as active RoM, were significantly improved (t test) in comparison with the mean preoperative values (p < 0.05). No significant differences were observed between the two groups in relation to the two success rate criteria (ASES minimal clinically important difference or MCID > 17, Constant score MCID > 10.4), as well as pain relief and RoM 12 months after surgery. CONCLUSION: Arthroscopic partial repair, either with or without ISB implantation, resulted in significantly improved clinical and functional short-term outcomes for the treatment of MRCT. Patients who were treated with combined partial repair and ISB implantation had a potential propensity toward better functional outcomes and higher patient satisfaction compared to the single-partial-repair-treated group. However, given that these differences were not significant, we feel that further studies are required to clarify the potential therapeutic value of ISB implantation in the treatment of irreparable MRCT. LEVEL OF EVIDENCE: Level III. CLINICAL TRIALS' REGISTRY: German Clinical Trials Register (WHO International Clinical Trials Registry Platform). ID number: DRKS00014725. Date of registration: 07/05/2018.
BACKGROUND: To investigate whether arthroscopic partial repair with the additional use of a biodegradable subacromial spacer would be proven better treatment for irreparable massive rotator cuff tears (MRCT) compared to single arthroscopic partial repair. METHODS: A matched-pairs case-control study of 32 patients suffering from irreparable MRCT who underwent an arthroscopic partial repair with (Group B: 16 patients) or without (Group A: 16 patients) InSpace Balloon (ISB®; Orthospace, Caesarea, Israel) implantation was conducted. For the clinical and functional assessment of the patients, the visual analog scale, Constant score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Range of Motion (RoM), and patients' satisfaction were obtained. RESULTS: The two groups were matched in all baseline demographic and clinical characteristics (n.s.). All mean final quantitative postoperative clinical and functional scores of group A (partial repair and ISB) and group B (single partial repair), as well as active RoM, were significantly improved (t test) in comparison with the mean preoperative values (p < 0.05). No significant differences were observed between the two groups in relation to the two success rate criteria (ASES minimal clinically important difference or MCID > 17, Constant score MCID > 10.4), as well as pain relief and RoM 12 months after surgery. CONCLUSION: Arthroscopic partial repair, either with or without ISB implantation, resulted in significantly improved clinical and functional short-term outcomes for the treatment of MRCT. Patients who were treated with combined partial repair and ISB implantation had a potential propensity toward better functional outcomes and higher patient satisfaction compared to the single-partial-repair-treated group. However, given that these differences were not significant, we feel that further studies are required to clarify the potential therapeutic value of ISB implantation in the treatment of irreparable MRCT. LEVEL OF EVIDENCE: Level III. CLINICAL TRIALS' REGISTRY: German Clinical Trials Register (WHO International Clinical Trials Registry Platform). ID number: DRKS00014725. Date of registration: 07/05/2018.
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