Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy.

INTRODUCTION: Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy. METHODS: A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy. RESULTS: Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results. CONCLUSION: In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs.

The rotator cuff refers to a group of four muscles, with tendons connected to the upper arm bone, which act together to allow lifting and rotating the shoulder. A tear of the rotator cuff can affect either a single tendon or multiple tendons. Typical first-line treatment includes conservative therapies, which aim to alleviate pain and reduce functional impairment, but are often ineffective. Persisting disease is usually managed through conventional surgical repair. Recently, REGENETEN, a collagen-based bioinductive implant derived from purified bovine Achilles tendon, positioned over the site of the damaged rotator cuff, achieved successful rotator cuff tendon repair with an increase in healed tears of 17.80% at 1 year compared to conventional surgery. Considering the National Healthcare Service perspective in Italy, the cost needed to achieve one additional healed tear using REGENETEN compared to conventional surgery is €17,857. From the societal perspective, which includes patients' productivity losses from hospital admission to return to work, the use of REGENETEN may be cost-saving compared to conventional surgery. The findings of our study provide evidence for clinicians and payers to support the value of a new treatment option for patients with rotator cuff lesions.

CT-scan Evaluation of Osteointegration and Osteolysis in Different Graft Types and Surgical Techniques for the Treatment of Shoulder Instability.

Background: Bone graft is often needed in treating anterior shoulder instability in glenoid bone loss and graft integration is crucial in achieving good results. This study aimed to evaluate bone graft remodeling in different techniques for shoulder anterior-inferior instability. Methods: Graft osteointegration and osteolysis were retrospectively evaluated with CT-scan imaging performed 6 to 12 months after surgery to compare the outcome of three procedures: Latarjet, bone block with allograft, and bone block with xenograft. Screw fixation and double endobuttons fixation were also compared. Results: CT scans of 130 patients were analyzed. Of these, 30 (23%) were performed after the bone block procedure with xenograft and endobuttons fixation, 55 (42%) after the bone block procedure with allograft and endobuttons fixation, 13 (10%) Latarjet with screw fixation and 32 (25%) Latarjet with endobuttons fixation. The prevalence of osteolysis was significantly inferior (P<.01) in the bone block procedure compared to the Latarjet procedure (11.7 % vs. 28.8 %). Bone integration was higher in bone block procedures (90.5%) than in Latarjet (84.4%), but the difference was not statistically significant. Among the Latarjet procedures, endobuttons fixation resulted in a higher integration rate (87.5% vs. 73.6%) and lower osteolysis rate than screw fixation (24.6% vs. 38.5%), despite these differences did not reach a statistical significance. Among the bone block procedures, using a xenograft resulted in a lower osteolysis rate (6.7%) than an allograft (14.5%), but the result was not statistically significant. Conclusion: This study shows a significantly lower rate of graft osteolysis after bone block procedures compared to Latarjet procedure between 6 and 12 months postoperatively. Moreover, our findings suggest good results in osteolysis and graft integration with xenograft compared to allograft and double endobuttons fixation compared to screw fixation, despite these differences being not-significant. Further studies on this topic are needed to confirm our results at a longer follow-up and thoroughly investigate the clinical relevance of these findings.

Arthroscopic Latarjet Procedure: A Technique Using Double Round ENDOBUTTONs and Specific Glenoid and Coracoid Guides.

The Latarjet procedure is a method used for the treatment of shoulder instability in the presence of bone loss. A decade after the first description of the fully arthroscopic Latarjet procedure, modifications to the technique were reported to decrease the risk of complications and improve the position of the bone block. A recent trend toward the use of buttons to fix the coracoid has been reported. The technique described here is an arthroscopic Latarjet procedure that uses 2 pairs of round buttons as an alternative to screw fixation or the use of a single button, and the technique aims to combine the original procedure with safe and stable fixation.

Ultrasound-Guided Percutaneous Tenotomy of the Long Head of Biceps Tendon in Patients with Symptomatic Complete Rotator Cuff Tear: In Vivo Non-contRolled Prospective Study.

BACKGROUND: We prospectively tested technical feasibility and clinical outcome of percutaneous ultrasound-guided tenotomy of long head of biceps tendon (LHBT). METHODS: We included 11 patients (6 women; age: 73 ± 8.6 years) with symptomatic full-thickness rotator cuff tear and intact LHBT, in whom surgical repair was not possible/refused. After ultrasound-guided injection of local anesthetic, the LHBT was cut with a scalpel under continuous ultrasound monitoring until it became no longer visible. Pain was recorded before and at least six months after procedure. An eight-item questionnaire was administered to patients at follow-up. RESULTS: A median of 4 tendon cuts were needed to ensure complete tenotomy. Mean procedure duration was 65 ± 5.7 s. Mean length of skin incision was 5.8 ± 0.6 mm. Pre-tenotomy VAS score was 8.2 ± 0.7, post-tenotomy VAS was 2.8 ± 0.6 (p < 0.001). At follow-up, 5/11 patients were very satisfied, 5/11 satisfied and 1/11 neutral. One patient experienced cramping and very minimal pain in the biceps. Six patients had still moderate shoulder pain, 1/11 minimal pain, 2/11 very minimal pain, while 2/11 had no pain. No patients had weakness in elbow flexion nor limits of daily activities due to LHBT. One patient showed Popeye deformity. All patients would undergo ultrasound-guided tenotomy again. CONCLUSION: ultrasound-guided percutaneous LHBT tenotomy is technically feasible and effective.

A new mini-open technique of arthroscopically assisted Latarjet.

BACKGROUND: The aim is to describe a new arthroscopically assisted Latarjet technique. METHODS: We evaluated the clinical and radiological findings of 60 patients with chronic recurrent anterior gleno-humeral instability who underwent, between September 2013 and November 2014, an arthroscopically-assisted Latarjet procedure with double round endobutton fixation. Inclusion criteria were: chronic anterior recurrent instability, Instability Severity Index Score (ISIS) greater than three points, a glenoid bone defect > 15% or a Hill Sachs lesion with concomitant glenoid bone defect > 10%. During surgery the joint capsule and the anterior glenoid labrum were detached. Two drill tunnels perpendicular to the neck of the glenoid were made through a guide. An accessible pilot hole through the glenoid was created to allows the passage of guidewires for coracoid guidance and final fixation onto the anterior glenoid. Through a restricted deltopectoral access a coracoid osteotomy was made. Finally, the graft was prepared, inserted and secured using half-stitches. RESULTS: The mean follow-up was 32.5 months (range 24-32 months). At a mean follow-up, 56 of the 60 subjects claimed a stable shoulder without postoperative complaints, two (3.3%) had an anterior dislocation after new traumatic injury, and two (3.3%) complained of subjective instability. At the latest follow-up, four subjects complained of painful recurrent anterior instability during abduction-external rotation with apprehension. At 1 year, the graft had migrated in one patient (1.7%) and judged not healed and high positioned in another patient (1.7%). Moreover, a glenoid bony gain of 26.3% was recorded. At the latest follow-up, three patients had grade 1 according to Samilson and Prieto classification asymptomatic degenerative changes. Nerve injuries and infections were not detected. None of the 60 patients underwent revision surgery. Healing rate of the graft was 96.7%. CONCLUSIONS: This technique of arthroscopically assisted Latarjet combines mini-open and arthroscopic approach for improving the precision of the bony tunnels in the glenoid and coracoid placement, minimizing any potential risk of neurologic complications. It can be an option in subjects with anterior gleno-humeral instability and glenoid bone defect. Further studies should be performed to confirm our preliminary results. TRIAL REGISTRATION: Trial registration number 61/int/2017 Name of registry: ORS Date of registration 11.5.2017 Date of enrolment of the first participant to the trial: September 2013 'retrospectively registered' LEVEL OF EVIDENCE: IV.

Arthroscopic Bone Graft Procedure Combined With Arthroscopic Subscapularis Augmentation for Recurrent Anterior Instability With Glenoid Bone Defect.

Glenoid bone loss and capsular deficiency represent critical points of arthroscopic Bankart repair failures. The purpose of this Technical Note is to present an all-arthroscopic bone block procedure associated with arthroscopic subscapularis augmentation for treating glenohumeral instability with glenoid bone loss and anterior capsulolabral deficiency. Two glenoid tunnels are set up from the posterior to the anterior side using a dedicated bone block guide, and 4 buttons are used to fix the graft to the glenoid. The subscapularis tenodesis is performed using a suture tape anchor. This combined arthroscopic technique (bone block associated with arthroscopic subscapularis augmentation) could be a valid and safe alternative to the arthroscopic or open Latarjet procedures.

An arthroscopic bone block procedure is effective in restoring stability, allowing return to sports in cases of glenohumeral instability with glenoid bone deficiency.

PURPOSE: A group of patients affected by bone loss in the context of recurrent anterior shoulder instability were treated arthroscopically with a modified Eden-Hybinette technique since 2005. The last modification was made in 2013, consisting of fixation using a pair of specifically designed double round Endobuttons, which secure the bone graft to the glenoid rim placed through a guide. This report describes patients operated on after this last modification. No reports have described the results of this technique, and the purpose of this study was to assess early clinical and radiological results of an arthroscopic bone block procedure with double round Endobutton fixation. We hypothesized that this technique would restore shoulder stability in patients with anteroinferior glenohumeral instability with glenoid bone deficit, with excellent clinical and radiological results. METHODS: The clinical and radiological efficacy of this procedure was retrospectively evaluated in 26 patients with an average follow-up of 29.6 months (range 24-33 months). RESULTS: At minimum 2-year follow-up, we had no recurrent anterior dislocations, excellent clinical results [average Walch-Duplay score 93.2, (SD 7.8); average Rowe score, 96.4 (SD 6.5); average SSV, 87.4 (SD 12.1); satisfaction rate, 88.5%; average loss of external rotation, 4.4° (SD 8.7°)] optimal graft positioning, and a healing rate of 92.3% on computed tomography scan. CONCLUSIONS: Arthroscopic bone block grafting combined with a standard Bankart repair restored shoulder stability in patients with anteroinferior glenohumeral instability with glenoid bone deficit, with excellent clinical and radiological results. This procedure did not substantially limit external rotation, allowing a high rate of return to sports even among competitive, overhead, and "at risk" athletes.

Arthroscopically-assisted Latarjet: an easy and reproducible technique for improving the accuracy of graft and screw placement.

BACKGROUND: The effectiveness of the Latarjet largely depends on accurate graft placement, as well as on proper position and direction of the screws. We present our technique for an arthroscopically-assisted Latarjet comparing radiological results with the open technique. METHODS: We retrospectively reviewed the postoperative computed tomography scans of 38 patients who underwent a Latarjet procedure. For 16 patients, the procedure was performed with the open technique and, for 22 patients, it was performed using an arthroscopically-assisted technique. An independent radiologist evaluated graft and hardware position, as well as graft integration or resorption. Postoperative complications were also documented. RESULTS: The graft was correctly placed in only 18.8% of cases in the open group and 72.7% of cases in the arthroscopically-assisted group. There were no postoperative complications in the arthroscopically-assisted group, whereas one patient had a recurrence and two required hardware removal in the open group. CONCLUSIONS: The Latarjet procedure is a challenging procedure for which a key point is the correct placement of the coracoid graft onto the glenoid neck and correct position of the screws. The present study substantiates a clear benefit for the use of a guide with an arthroscopically-assisted technique in terms of graft and hardware placement. At short-term follow-up, there appears to be a benefit for graft integration and avoidance of resorption.

Arthroscopic bone graft procedure combined with arthroscopic subscapularis augmentation (ASA) for recurrent anterior instability with glenoid bone defect: a cadaver study.

BACKGROUND: Glenoid bone loss and capsular deficiency represent critical points of arthroscopic Bankart repair failures. The purpose of this study was to evaluate an all-arthroscopic bone block procedure associated with arthroscopic subscapularis augmentation (ASA) for treating gleno-humeral instability with glenoid bone loss (GBL) and anterior capsulo-labral deficiency. Our hypothesis was that these two procedures could be combined arthroscopically. The feasibility of this technique and its reproducibility, and potential neurovascular complications were evaluated. METHODS: A tricortical bone graft was harvested from the cadaveric clavicle, and in one case a Xenograft was used. An anterior-inferior GBL of about 25% was created. Two glenoid tunnels were set up from the posterior to the anterior side using a dedicated bone block guide, and four buttons were used to fix the graft to the glenoid. The subscapularis tenodesis was performed using a suture tape anchor. Afterwards, the shoulder was dissected to study the relationship between all portals and nerves. The size of the bone block, its position on the glenoid and the relationship with the subscapularis tendon were investigated. RESULTS: In all seven specimens (five left and two right shoulders), the bone block was flush with the cartilage and fixed to the anterior-inferior part of the glenoid. No lesions of the surrounding neurovascular structures were observed. No interference was found between the two bone block tunnels and the anchor tunnel used for the tenodesis. CONCLUSIONS: This study demonstrated the feasibility and reproducibility of this combined arthroscopic technique (bone block associated with ASA) in the treatment of anterior shoulder instability associated with anterior bone loss and anterior capsular deficiency.

Arthroscopic Reduction with Endobutton Fixation for Glenoid Fracture.

Glenoid rim fractures, accompanied by acute glenohumeral dislocation or subluxation usually results in persistent instability. Traditionally open reduction and internal fixation has been recommended in displaced intra-articular glenoid fractures. However, open reduction is difficult, and it may not be possible to address the associated intra-articular soft-tissue injuries. A few reports of arthroscopic-assisted fixation of these fractures have been recently published. The most anatomic method for addressing an acute glenoid rim lesion is a reduction (either open or arthroscopic) and internal fixation. We are reporting a case of arthroscopic reduction and fixation of a glenoid fracture utilizing Endobuttons with clinical and radiological results at 18 months follow-up.

Arthroscopic treatment of glenoid bone loss.

Recurrent anterior instability of the glenohumeral joint has long been an arduous problem to solve surgically, owing to its difficulty to the need to restore both osseous and dynamic constraints in the unstable shoulder. Biomechanical studies have indicated that glenoid bone loss shortens the safe arc through which the glenoid can resist axial forces; in these cases, a soft tissue repair alone may be insufficient to maintain stability. Clinical studies have confirmed that major bone loss is associated with an unfavourable outcome. The benefits of using arthroscopic procedures for surgical stabilization of the shoulder include smaller incisions and less soft tissue dissection, better access for repair and, potentially, the maximum respect for the undamaged anatomical structures. The biggest disadvantage of arthroscopic procedures until recently was the inability to successfully treat a significant bone defect. Over the last 10 years, several new arthroscopic techniques have been developed, providing new surgical options for successfully treating soft tissues and bony lesions in anterior-inferior glenohumeral instability. Level of evidence V.

One step arthroscopically assisted Latarjet and posterior bone-block, for recurrent posterior instability and anterior traumatic dislocation.

This case presents the challenges of the surgical management for a patient with a history of recurrent posterior shoulder instability and subsequently traumatic anterior dislocation. The patient was already on the waiting list for an arthroscopic posterior stabilization with anchors, when a car accident caused an additional anterior shoulder dislocation. This traumatic anterior dislocation created a bone loss with a glenoid fracture and aggravated the preexisting posterior instability. In order to address both problems, we decided to perform an arthroscopically assisted Latarjet procedure for anterior instability and to stabilize with a bone graft for posterior instability. To our best knowledge, this type of surgical procedure has so far never been reported in the literature. The purpose of this report is to present the surgical technique and to outline the decision making process.

Arthroscopic bone graft procedure for anterior inferior glenohumeral instability.

There are many described surgical techniques for the treatment of recurrent anterior shoulder instability. Numerous authors have performed anterior bone block procedures with good results for the treatment of anterior shoulder instability with glenoid bone loss. The benefits of using arthroscopic procedures for surgical stabilization of the shoulder include smaller incisions with less soft-tissue dissection, better visualization of the joint, better repair accessibility, and the best possible outcome for external rotation. We describe an arthroscopic anteroinferior shoulder stabilization technique with an iliac crest tricortical bone graft and capsulolabral reconstruction. It is an all-arthroscopic technique with the advantage of not using fixation devices, such as screws, but instead using special buttons to fix the bone graft. The steps of the operation are as follows: precise placement of a specific posterior glenoid guide that allows the accurate positioning of the bone graft on the anterior glenoid neck; fixation of the graft flush with the anterior glenoid rim using specific buttons under arthroscopic control; and finally, subsequent capsular, labral, and ligament reconstruction on the glenoid rim using suture anchors and leaving the graft as an extra-articular structure.

Arthroscopically assisted Latarjet procedure: A new surgical approach for accurate coracoid graft placement and compression.

The Latarjet procedure is a confirmed method for the treatment of shoulder instability in the presence of bone loss. It is a challenging procedure for which a key point is the correct placement of the coracoid graft onto the glenoid neck. We here present our technique for an athroscopically assisted Latarjet procedure with a new drill guide, permitting an accurate and reproducible positioning of the coracoid graft, with optimal compression of the graft onto the glenoid neck due to the perfect position of the screws: perpendicular to the graft and the glenoid neck and parallel between them.

The frequency of subscapularis tears in arthroscopic rotator cuff repairs: A retrospective study comparing magnetic resonance imaging and arthroscopic findings.

PURPOSE: With the advent of arthroscopic shoulder surgery the comprehension and description of rotator cuff tears have strongly evolved. Subscapularis tears are difficult to recognize and are underestimated. Our purpose is to report our observations concerning the relative frequency of subscapularis tears in patients undergoing arthroscopic rotator cuff repair and to compare the arthroscopic observations with the magnetic resonance imaging (MRI) findings. MATERIALS AND METHODS: Retrospective cohort study including all patients undergoing arthroscopic rotator cuff repair was performed between March 2006 and March 2009 at our institution. Preoperative MRI findings, intraoperative arthroscopic findings, and details of surgical intervention were collected using medical charts. RESULTS: We reviewed the medical charts of a total of 348 consecutive arthroscopic rotator cuff repairs. There were 311 supraspinatus tears (89%), 48 infraspinatus tears (14%), and 129 subscapularis tears (37%). MRI sensitivity and specificity were respectively 0.25 and 0.98 for subscapularis tendon tears, 0.67 and 1.0 for supraspinatus tears and 0.5 and 0.99 for infraspinatus tears. CONCLUSION: Subscapularis tears are frequent lesions and usually appear concomitantly with supra or infraspinatus lesions. We propose a classification of subscapularis tendon tears, based on our observations of the pathoanatomy of the tears. While concordance with MRI results are good for the supraspinatus, MRI often fails to diagnose the presence of subscapularis tears and infraspinatus tears.

Radiofrequency-based plasma microtenotomy compared with arthroscopic subacromial decompression yields equivalent outcomes for rotator cuff tendinosis.

PURPOSE: This study aimed to determine whether radiofrequency (RF)-based plasma microtenotomy (microdebridement) was effective for treating chronic supraspinatus tendinosis. METHODS: The institutional ethics committee approved the study design, and all patients signed informed consent forms. Patients (age range, 30 to 70 years) were considered for enrollment if 6 months of active conservative treatment had failed and they had Neer stage II impingement syndrome, positive radiographic evidence of type II acromion, and magnetic resonance imaging or ultrasound evidence of supraspinatus tendinosis. Patients (N = 60) were randomly assigned to undergo arthroscopic subacromial decompression or RF-based plasma microtenotomy. For microtenotomy, a bipolar RF-based probe (TOPAZ; ArthroCare, Austin, TX) was used to perform microdebridement in the supraspinatus tendon; patients did not undergo acromioplasty. Outcomes evaluation consisted of self-reported pain via a visual analog scale, as well as functional assessment (American Shoulder and Elbow Surgeons [ASES] survey, Constant score, and University of California, Los Angeles [UCLA] questionnaire). Statistical analyses were performed by use of factorial dependent-measures analysis of variance tests. RESULTS: Age and baseline scores on the visual analog scale (mean +/- SD) were 52.0 +/- 6.7 and 53.2 +/- 6.6 years and 8.4 +/- 0.9 and 8.2 +/- 0.8 points in the microtenotomy and arthroscopic subacromial decompression groups, respectively. A significant reduction in pain (P < .001) and improved function (P < .001 for all measures) were observed in both groups postoperatively. Both treatment groups had almost identical longitudinal recovery profiles for pain relief (P = .416) and restoration of function (P = .964 for ASES score, P = .978 for Constant score, and P = .794 for UCLA score). At 1 year, the median pain score was 1.0, and all patients had ASES, Constant, and UCLA scores of greater than 90, greater than 80, and greater than 30, respectively. CONCLUSIONS: Both procedures were associated with significant improvement postoperatively, but the RF-based plasma microtenotomy procedure draws into question the need for a more extensive procedure such as subacromial decompression in this patient population. LEVEL OF EVIDENCE: Level I, therapeutic randomized controlled study.

Adhesive capsulitis of the shoulder in human immunodeficiency virus-positive patients during highly active antiretroviral therapy.

Many adverse events have been described in patients treated with highly active antiretroviral therapy (HAART). Recently, among these, adhesive capsulitis of the shoulder has been described in some patients using protease inhibitors. We report our experience with 6 human immunodeficiency virus-positive patients in whom adhesive capsulitis of the shoulder developed during HAART. All 6 patients were treated with the same antiretroviral drug combination (HAART) including nucleoside reverse transcriptase (stavudine and lamivudine) and protease inhibitors (indinavir). The clinical pattern of adhesive capsulitis during HAART is similar to the classical form of adhesive capsulitis. Examining our case studies, we postulate a correlation between HAART and adhesive capsulitis. Discontinuation or reduction of the dosage of protease inhibitors associated with conventional conservative treatment is effective in reducing the symptoms and resolving the disease.

Arthroscopic treatment for greater tuberosity fractures: rationale and surgical technique.

A description of a new technique for arthroscopic treatment of minimally displaced greater tuberosity fractures of the humerus and associated soft tissue lesions is presented. This kind of fracture is usually treated nonsurgically. However, recent evidence suggests that even a small amount of superior displacement may produce shoulder dysfunction and require a perfect surgical reduction and fixation. Moreover, any displaced fracture of the greater tuberosity presents a high rate of associated and largely undetected soft tissue lesions. To avoid underestimating accompanying soft tissue pathology, arthroscopic assessment before open treatment of greater tuberosity fractures has been suggested. In 2 earlier case reports, we described the use of an arthroscope not only to diagnose and treat a rotator cuff tear and a Bankart lesion associated with a minimally displaced greater tuberosity fracture but also to arthroscopically reduce and treat the fracture. With advancements in arthroscopy and equipment, we refined and systematized the original arthroscopic technique that we have routinely used since 1997. This article presents the new technique.

Arthroscopic rotator interval repair: the three-step all-inside technique.

Many clinical reports have emphasized the importance of rotator interval lesions in patients with glenohumeral instability, and many investigators have described open repair techniques, either as a supplement to other capsule reconstruction or as an isolated procedure. In this article, an original arthroscopic technique for rotator interval closure is described. This technique allows the operator to accurately manage the degree of tightening of the rotator interval, the knot tying, and the suture cutting, under direct intra-articular arthroscopic vision.