Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial.

BACKGROUND: Historically, in-person physical therapy serves as a foundational component of nonoperative treatment of adhesive capsulitis (AC). This study compares the effectiveness of an at-home high-intensity stretch (HIS) device to traditional physical therapy (PT) and to PT in combination with the HIS device. We hypothesize that the HIS device will be as effective as PT alone or as combination therapy in the first-line treatment of AC and use of the HIS device will exhibit improvement at higher rate. METHODS: Thirty-four patients with idiopathic adhesive capsulitis and a minimum of 12 months follow-up were included in this study. Patients were randomized into one of the three groups: HIS device, PT alone, or HIS device + PT. Passive range of motion (ROM), American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) scores were measured. Additionally, patient satisfaction, compliance and complications were recorded. Paired t-test, ANOVA and Chi-squared tests were used in analysis. RESULTS: Final ROM in all planes improved for all groups compared to baseline (p < 0.001), with only HIS device group able to restore > 95% of contralateral ROM in all planes at final follow-up. Patients with PT alone were on average slowest to improve ROM from baseline, at 3 months, 6 months, and 1 year in all planes except internal rotation. ASES and SST scores improved for all groups when compared to baseline (p < 0.001). Use of HIS-device resulted in greater improvement in SST and ASES Total scores compared to PT alone (p = 0.045, and p = 0.048, respectively). CONCLUSIONS: Use of an at-home high-intensity stretching device for conservative treatment of idiopathic adhesive capsulitis improves outcomes in ROM and in ASES and SST scores both when used as an adjunct to physical therapy and when used alone. TRIAL REGISTRATION: The study protocol was registered at www. CLINICALTRIALS: gov (20/05/2022, NCT05384093).

An Injectable Calcium Phosphate Bone Graft Substitute Improves the Pullout Strength of Various Suture Anchor Designs in an Osteoporotic Bone Model.

Purpose: To compare various suture anchor designs with and without calcium phosphate (CaP) augmentation in an osteoporotic foam block model and decorticated proximal humerus cadaveric model. Methods: This was a controlled biomechanical study, consisting of 2 parts: (1) an osteoporotic foam block model (0.12 g/cc; n = 42) and (2) a matched pair cadaveric humeral model (n = 24). Suture anchors selected were an all-suture anchor, PEEK (polyether ether ketone)-threaded anchor, and a biocomposite-threaded anchor. For each study arm, one half the samples were first filled with injectable CaP and the other half were not augmented with CaP. For the cadaveric portion, the PEEK- and biocomposite-threaded anchors were assessed. Biomechanical testing consisted of a stepwise, increasing load protocol for a total of 40 cycles, followed by ramp to failure. Results: For the foam block model, the average load to failure for anchors with CaP was significantly greater when compared with anchor fixation augmented without CaP; the all-suture anchor was 135.2 ± 20.2 N versus 83.3 ± 10.3 N (P = .0006); PEEK was 131 ± 34.3 N versus 58.5 ± 16.8 N (P = .001); and biocomposite was 182.2 ± 64.2 N versus 80.8 ± 17.4 N (P = .004). For the cadaveric model, the average load to failure for anchors augmented with CaP was again greater than anchor fixation without CaP; PEEK anchors went from 41.1 ± 21.1 N to 193.6 ± 63.9 N (P = .0034) and biocomposite anchors went from 70.9 ± 26.6 N to 143.2 ± 28.9 N (P = .004). Conclusions: Augmenting various suture anchors with CaP has shown to significantly increase pull-out strength and stiffness in an osteoporotic foam block and time zero cadaveric bone model. Clinical Relevance: Rotator cuff tears are common in the elderly patients, in whom poor bone quality jeopardizes treatment success. Exploring methods that increase the strength of fixation in osteoporotic bone to improve outcomes in this patient population is important.

Interpositional scaffold anchor rotator cuff footprint tear repair: excellent survival, healing, and early outcomes.

PURPOSE: Shoulder function limitation duration after a full-thickness rotator cuff tendon (RCT) tear may influence post-repair healing and outcomes. A suture anchor was developed to improve footprint repair fixation and healing through biological fluid delivery and scaffold augmentation. The primary multicenter study objective was to evaluate RCT repair failure rate based on 6-month MRI examination, and device survival at 1-year follow-up. The secondary objective was to compare the clinical outcomes of subjects with shorter- and longer-term shoulder function limitation duration. METHODS: Seventy-one subjects (46 men) with moderate-to-large RCT tears (1.5-4 cm), at a median 61 years of age (range = 40-76), participated in this study. Pre-repair RCT tear location/size and 6-month healing status were confirmed by an independent radiologist. Subjects with shorter- (Group 1: 17.8 ± 21 days, n = 37) and longer-term (Group 2: 185.4 ± 89 days, n = 34) shoulder function limitation durations were also compared over 1 year for active mobility, strength, American Shoulder and Elbow Surgeon's Shoulder Score (ASES score), Veterans RAND 12 Item Health Survey (VR-12), and visual analog scale (VAS) pain and instability scores. RESULTS: Three of the 52 subjects [5.8%] who underwent 6-month MRI experienced a re-tear at the original RCT footprint repair site. By the 1-year follow-up, overall anchor survival was 97%. Although Group 2 displayed lower ASES and VR-12 scores pre-repair (ASES = 40.1 ± 17 vs. 47.9 ± 17; VR-12 physical health (PH) = 37.2 ± 9 vs. 41.4 ± 8) (p ≤ 0.048), at 3-month post-RCT repair (ASES = 61.3 ± 19 vs. 71.3 ± 20; VR-12 PH = 40.8 ± 8 vs. 46.8 ± 9) (p ≤ 0.038), and at 6-month post-RCT repair (ASES = 77.4 ± 18 vs. 87.8 ± 13; VR-12 PH = 48.9 ± 11 vs. 54.0 ± 9) (p ≤ 0.045), by 1-year post-RCT repair, groups did not differ (n.s.). Between-groups VR-12 mental health score differences were not evident at any time period (n.s.). Shoulder pain and instability VAS scores also did not differ (n.s.), displaying comparable improvement between groups from pre-RCT repair to 1-year post-RCT repair. Groups had comparable active shoulder mobility and strength recovery at each follow-up (n.s.). CONCLUSION: At 6-month post-RCT repair, only 3/52 of patients [5.8%] had a footprint re-tear, and at 1-year follow-up, overall anchor survival was 97%. Use of this scaffold anchor was associated with excellent early clinical outcomes regardless of shoulder function impairment duration. LEVEL OF EVIDENCE: II.

Calcium Phosphate Bone Void Filler Increases Threaded Suture Anchor Pullout Strength: A Biomechanical Study.

PURPOSE: To compare the response to cyclical loading and ultimate pull-out strength of threaded suture anchor with and without calcium phosphate bone void filler augmentation in a polyurethane foam block model and in vitro proximal humerus cadaveric model. METHODS: This controlled biomechanical study consisted of 2 parts: (1) preliminary polyurethane foam block model, and (2) in vitro cadaveric humeri model. The preliminary foam block model intended to mimic osteoporotic bone using a 0.12 g/mL foam material. Half of the foam block models were first filled with injectable calcium phosphate bone substitute material (CP-BSM), whereas the other half were not augmented with CP-BSM. Each specimen was then instrumented with a threaded suture anchor. The same technique and process was performed in a matched cadaveric humeri model. Testing then consisted of a stepwise, increasing axial load protocol for a total of 40 cycles. If the anchor remained intact after cyclic loading, the repair was loaded to failure. The number of completed cycles, failure load, and failure modes were compared between groups. RESULTS: Average pull-out strength for suture anchor with CP-BSM in the osteoporotic foam block model was significantly higher at 332.68 N ± 47.61 compared with the average pull-out strength of suture anchor without CP-BSM at 144.38 N ± 14.58 (P = .005). In the matched cadaveric humeri model, average pull-out strength for suture anchor with CP-BSM was significantly higher at 274.07 N ± 102.07 compared with the average pull-out strength of suture anchor without CP-BSM at 138.53 N ± 109.87 (P = .029). CONCLUSIONS: In this time zero, biomechanical study, augmentation of osteoporotic foam block and cadaveric bone with calcium phosphate bone substitute material significantly increases pull-out strength of threaded suture anchors. CLINICAL RELEVANCE: Considering concerns about suture anchor pull-out from osteoporotic bone, augmentation with calcium phosphate bone substitute material increases load to failure resistance.

Organ donation as an outcome of traumatic cardiopulmonary arrest: A cost evaluation.

BACKGROUND: Survival after traumatic cardiopulmonary arrest (TCPA) is rare and requires significant resource expenditure. Organ donation as an outcome of TCPA resuscitation has not yet been included in a cost analysis. The aims of this study were to identify variables associated with survival and organ donation after TCPA, and to estimate the cost of achieving these outcomes. We hypothesized that the inclusion of organ donation as a potential outcome would make TCPA resuscitation more cost-effective. METHODS: Adult patients who required resuscitation for TCPA at a level I trauma center were retrospectively reviewed over 36 months. Data were obtained from medical records, hospital accounting records, and the local organ procurement agency. Outcomes included survival to discharge, neurologic function, and organ donor eligibility. An individual-level state-transition cost-effectiveness model was used to evaluate the cost of TCPA resuscitation with and without organ donation included as an outcome. Incremental cost-effectiveness ratio was calculated to determine additional cost per life saved when organ donation is included. RESULTS: Over the study period, 8,932 subjects were evaluated. Traumatic cardiopulmonary arrest occurred in 237 patients (3%). The mortality rate was 97%. Variables associated with survival included emergency department disposition to the operating room (p < 0.01) and reactive pupils (p < 0.001). Of seven survivors, four were discharged neurologically intact. Of the patients with TCPA, 5% were eligible for organ donation with a procurement rate of 2%. Organ donor eligibility was associated with arrest after arrival to the emergency department (p < 0.01) and transfusion of fresh frozen plasma (p = 0.01). The cost of TCPA resuscitation per survivor was $1.8 million; cost per survivor or life saved by donation was $538,000. The incremental cost-effectiveness ratio was $76,816 per additional life saved including donation as an outcome. CONCLUSION: The decision to pursue resuscitation should continue to be based on the presence of signs of life, especially pupil reactivity and duration of arrest. If the primary objective is survival, organ procurement will be maximized without conflict of interest. Early fresh frozen plasma transfusion may increase successful organ donation. The financial burden of TCPA resuscitation can be mitigated by expanding end points to include organ donation. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, level III; cost analysis, level V.