The subacromial balloon spacer for massive irreparable rotator cuff tears: approximately 3 years of prospective follow-up.

BACKGROUND: Irreparable rotator cuff tears (RCT) are still a challenging problem. RCT can result in disability and severe pain. The optimal treatment for this disabling and painful diagnosis remains controversial. The arthroscopic implantation of a biodegradable subacromial balloon spacer is a possible treatment option. In this prospective study, we evaluate the clinical outcome of this balloon spacer after approximately 3 years. METHODS: Between March 2014 and December 2015, the biodegradable balloon spacer was implanted into the subacromial space of 46 shoulders of 44 patients with massive irreparable RCT. Pain was evaluated using a numeric rating scale (NRS), and functional outcome was evaluated using the Oxford shoulder score (OSS). Patients were followed prospectively for approximately 3 years. This present study focuses on the comparison between the early and the midterm results up to approximately 3 years. RESULTS: All patients were treated by surgical implantation of the subacromial balloon spacer. The comparison between the outcomes of the NRS and the OSS after one and 3 years was made and showed no mutual significant differences, respectively, p = 0.61 and p = 0.08. Significant pain reduction and functional improvement was noticed postoperatively and maintained after approximately 3 years. At last follow-up (mean: 34 months), pain was reduced to a NRS of 3.09 points (95% CI: 2.17-4.01). Functional outcome based on the OSS improved significantly from 21.32 preoperatively to 34.39 (95% CI: 29.17-36.70) at the last follow-up. Correction for estimated confounders did not show significant differences. 82% of the patients were satisfied with the outcome after implantation of the subacromial balloon spacer. No surgical or postoperative medical complications due to implantation of the balloon spacer were reported. CONCLUSIONS: Arthroscopic implantation of the biodegradable balloon spacer in the subacromial space is a safe and minimally invasive intervention. It leads to significant reduction in pain and significant improvement of functional daily activities in patients with irreparable RCT during 3 years of follow-up starting postoperative and maintain over time beyond device degradation. A high percentage of patients are satisfied postoperatively. Despite of these positive results after 3 years of follow-up, the specific contribution of the balloon needs further investigation.

Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear.

BACKGROUND: Massive rotator cuff tear (RCT) can result in disability and severe pain. When conservative treatment fails, surgical treatment should be considered, as various surgical options can provide relatively satisfactory results. However, choosing an optimal treatment remains controversial. A relatively new treatment for irreparable RCT is the arthroscopic implantation of a biodegradable balloon spacer into the subacromial space. Here, we examined whether placement of this balloon spacer reduces pain and improves functional outcome in patients with an irreparable RCT. Patients were followed for 1 year following implantation. METHODS: In this prospective single-arm study, a biodegradable balloon spacer was implanted into the subacromial space of patients with a massive RCT. Pain was evaluated using a numeric rating scale (NRS), and functional outcome was evaluated using the Oxford shoulder score (OSS) and the Constant-Murley shoulder score (CMS). Five follow-up visits were performed during the first postoperative year. RESULTS: Forty-six shoulders in 44 patients with massive RCT were treated by surgical implantation of the subacromial balloon spacer. The mean reduction in NRS score was 3.5 points (95% CI 2.5-4.4), and 74% of patients achieved the minimal clinically important difference of 2 points by the 1-year follow-up visit. Functional outcome improved significantly based on OSS and CMS scores, and 80% of patients reported that they were satisfied with their outcome. No surgical or postoperative medical complications due to implantation of the balloon spacer were reported. CONCLUSIONS: Our results suggest that arthroscopic implantation of a biodegradable balloon spacer in the subacromial space significantly reduces pain and improves activities of daily living in patients with massive RCT during 1 year of follow-up. The specific contribution of the balloon with respect to improved clinical outcome needs further study, ideally in a randomized controlled trial.

Effect of transforming growth factor-beta and growth differentiation factor-5 on proliferation and matrix production by human bone marrow stromal cells cultured on braided poly lactic-co-glycolic acid scaffolds for ligament tissue engineering.

Tissue engineering of ligaments based on biomechanically suitable biomaterials combined with autologous cells may provide a solution for the drawbacks associated with conventional graft material. The aim of the present study was to investigate the contribution of recombinant human transforming growth factor beta 1 (rhTGF-beta1) and growth differentiation factor (GDF)-5, known for their role in connective tissue regeneration, to proliferation and matrix production by human bone marrow stromal cells (BMSCs) cultured onto woven, bioabsorbable, 3-dimensional (3D) poly(lactic-co-glycolic acid) scaffolds. Cells were cultured for 12 days in the presence or absence of these growth factors at different concentrations. Human BMSCs attached to the suture material, proliferated, and synthesized extracellular matrix rich in collagen type I and collagen III. No differentiation was demonstrated toward cartilage or bone tissue. The addition of rhTGF-beta1 (1-10 ng/mL) and GDF-5 (10-100 ng/mL) increased cell content (p < 0.05), but only TGF-beta1 also increased total collagen production (p < 0.05) and collagen production per cell, which is a parameter indicating differentiation. In conclusion, stimulation with rhTGF-beta1, and to a lesser extent with GDF-5, can modulate human BMSCs toward collagenous soft tissue when applied to a 3D hybrid construct. The use of growth factors could play an important role in the improvement of ligament tissue engineering.

Tissue engineering of ligaments: a comparison of bone marrow stromal cells, anterior cruciate ligament, and skin fibroblasts as cell source.

Anterior cruciate ligament (ACL) reconstruction surgery still has important problems to overcome, such as "donor site morbidity" and the limited choice of grafts in revision surgery. Tissue engineering of ligaments may provide a solution for these problems. Little is known about the optimal cell source for tissue engineering of ligaments. The aim of this study is to determine the optimal cell source for tissue engineering of the anterior cruciate ligament. Bone marrow stromal cells (BMSCs), ACL, and skin fibroblasts were seeded onto a resorbable suture material [poly(L-lactide/glycolide) multifilaments] at five different seeding densities, and cultured for up to 12 days. All cell types tested attached to the suture material, proliferated, and synthesized extracellular matrix rich in collagen type I. On day 12 the scaffolds seeded with BMSCs showed the highest DNA content (p < 0.01) and the highest collagen production (p < 0.05 for the two highest seeding densities). Scaffolds seeded with ACL fibroblasts showed the lowest DNA content and collagen production. Accordingly, BMSCs appear to be the most suitable cells for further study and development of tissue-engineered ligament.