Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study.

OBJECTIVE: To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. DESIGN: Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. SETTING: Six hospitals in Norway and Sweden. PARTICIPANTS: 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. INTERVENTIONS: Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. MAIN OUTCOME MEASURES: The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. RESULTS: Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. CONCLUSIONS: This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. TRIAL REGISTRATION: NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Interrater reliability of physical examination tests in the acute phase of shoulder injuries.

BACKGROUND: The physical examination is one of the cornerstones of the diagnostic process in patients with acute shoulder injuries. The discriminative properties of a given examination test depend both on its validity and reliability. The aim of the present study was to assess the interrater reliability of 13 physical examination manoeuvres for acute rotator cuff tears in patients with acute soft tissue shoulder injuries. METHODS: In a large walk-in orthopaedic emergency department, 120 consecutive patients ≥40 years of age were included in a diagnostic study. Patients who had follow-up within three weeks of an acute shoulder injury without fracture on radiographs were eligible. Four emergency department physicians participated as examiners. In a subset of 48 patients, the physical examination tests were performed by two physicians, randomly chosen by their work rotation. The physicians were blinded to the findings of each other and the results of the ultrasound screening. The interrater reliability was assessed by Cohen's kappa, intraclass correlation coefficient (ICC), standard error of measurement (SEM) and Bland-Altman plots depending on whether the examination test result was registered as a binary, ordered categorical or continuous numerical variable. RESULTS: The median age was 55.5 years, 46% were female. Twenty-seven percent had a rotator cuff full-thickness tear on ultrasound screening; all but one involved the supraspinatus tendon. Cohen's kappa for binary tests ranged from excellent to fair. Excellent agreement (kappa > 0.8) was found for the inability to abduct above 90° and abduction strength. External rotation strength expressed substantial agreement (kappa 0.7). The lowest scores were registered for Hawkins` test and the external rotation lag sign (kappa 0.25 and 0.40, respectively). The ICCs for active range of abduction and external rotation were 0.93 (0.88-0.96) and 0.84 (0.72-0.91), whereas the SEM was 15 and 9, respectively. CONCLUSIONS: The results indicate that examination manoeuvres assessing abduction and external rotation range of motion and strength are more reliable than manoeuvres assessing pain in patients in the acute phase of traumatic shoulder injury. The poor agreement observed is likely to limit the validity in the present setting of two commonly used tests. TRIAL REGISTRATION: The Norwegian Regional Ethics Committee South East ( 2015/195 ).

Sports-related acute shoulder injuries in an urban population.

OBJECTIVES: More than a third of sports injuries involve the upper extremity. The primary aim was to quantify and describe sports-related shoulder injuries in a general population cohort. A secondary aim was to compare aspects of these injuries to those that were not sports-related. METHODS: We performed a prospective registration of the activity at the time of shoulder injury in all cases admitted during 1 year in a combined primary care and orthopaedic emergency department serving a defined population. The electronic patient records and patient reported questionnaires were reviewed. RESULTS: Twenty-nine per cent (n=781) of 2650 registered shoulder injuries were reported to be sports-related, with the highest proportion in acromioclavicular injuries (>50%). Patients with sports injuries were younger than those injured during other activities (median age 28 and 43 years, respectively, p<0.001), and more often male (78% and 52%, respectively, p<0.001). There was a strong gender disparity in incidence of sports-related shoulder injuries in adolescents and young adults, which was not observed in non-sports shoulder injuries. Football (soccer) (6-29 years), cycling (30-49 years), skiing (50-69 years) and martial arts were the dominating sports activities. Fractures were more common in skiing and cycling than in other major sports in the study. CONCLUSIONS: Almost a third of the shoulder injuries occurred during sports. The types of sports involved varied with age and gender. The comparison of sport to non-sport shoulder injury incidence rates suggests that the increased risk of shoulder injuries in young males is mainly attributable to sports injuries.

At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears.

BACKGROUND: Tendon repair and physiotherapy are frequently used treatment methods for small and medium-sized rotator cuff tears. In 2 previous publications of the 1 and 5-year results of this study, we reported significant but small between-group differences in favor of tendon repair. Long-term results are needed to assess whether the results in both groups remain stable over time. METHODS: In this study, 103 patients with a rotator cuff tear not exceeding 3 cm were randomly assigned to primary tendon repair or physiotherapy with optional secondary repair. Blinded follow-up was performed after 6 months and 1, 2, 5, and 10 years. Outcome measures included the Constant score; the self-report section of the American Shoulder and Elbow Surgeons score; the measurement of shoulder pain, motion, and strength; and patient satisfaction. Magnetic resonance imaging (MRI) was performed on surgically treated shoulders after 1 year, and ultrasound was performed on all shoulders after 5 and 10 years. The main analysis was by 1-way analysis of covariance and by intention to treat. RESULTS: Ninety-one of 103 patients attended the last follow-up. After 10 years, the results were better for primary tendon repair, by 9.6 points on the Constant score (p = 0.002), 15.7 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.8 cm on a 10-cm visual analog scale for pain (p < 0.001), 19.6° for pain-free abduction (p = 0.007), and 14.3° for pain-free flexion (p = 0.01). Fourteen patients had crossed over from physiotherapy to secondary surgery and had an outcome on the Constant score that was 10.0 points inferior compared with that of the primary tendon repair group (p = 0.03). CONCLUSIONS: At 10 years, the differences in outcome between primary tendon repair and physiotherapy for small and medium-sized rotator cuff tears had increased, with better results for primary tendon repair. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair.

INTRODUCTION: Rotator cuff tear is a very common and disabling condition that can be related to acute trauma. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears. Despite its widespread use and almost a gold standard position, the efficacy of an arthroscopic rotator cuff repair is still unknown. The objective of this trial is to investigate the difference in outcome between arthroscopic rotator cuff repair and inspection of the shoulder joint defined as placebo surgery in patients 45-70 years of age with an acute rotator tear related to trauma. METHODS AND ANALYSIS: Acute Cuff Tear Repair Trial (ACCURATE) is a randomised, placebo-controlled, multicentre efficacy trial with sample size of 180 patients. Concealed allocation is done in 1:1 ratio. The randomisation is stratified according to participating hospital, gender and baseline Western Ontario Rotator Cuff Index (WORC). Both groups receive the same standardised postoperative treatment and physiotherapy. The primary outcome measure is the change in WORC score from baseline to 2-year follow-up. Secondary outcome measures include Constant-Murley Score, the Numerical Rating Scale for pain, subjective patient satisfaction and the health-related quality of life instrument 15 dimensions (15D). Patients and outcome assessors are blinded from the allocated intervention. The primary analysis of results will be conducted according to intention-to-treat analysis. ETHICS AND DISSEMINATION: The study protocol for this clinical trial has been approved by the Ethics Committee of the Hospital District of Southwest Finland and Regional Ethics Committee in Linköping Sweden and Regional Committees for Medical and Health Research Ethics South East in Norway. Every recruiting centre will apply local research approvals. The results of this study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02885714; Pre-results.

Shoulder injuries from birth to old age: A 1-year prospective study of 3031 shoulder injuries in an urban population.

INTRODUCTION: Shoulder injuries are commonly encountered in emergency departments. In spite of this, the epidemiology is only partly known, and soft tissue injuries in particular remain unclear. The aim of this study was to obtain an overview of shoulder injuries in a general population cohort, and to estimate the relative proportion of the main injury categories soft tissue injuries, fractures and dislocations, as well as their variation with age and gender. PATIENTS AND METHODS: We registered prospectively all patients admitted with a suspected shoulder injury at a combined casualty and primary health care facility during one year. The facility serves all hospitals and all citizens of Oslo. The patient-reported questionnaires, electronic patient records and radiology reports were examined. RESULTS: 3031 shoulder injuries were registered from May 2013 through April 2014. The median age was 37 years (range 14 days-102 years), 51 years in women and 31 years in men (p < 0.001), 60% were male. The male/female shoulder injury incidence rate ratio in the 20-34 years age group was 3.6 (95%CI, 3.0 to 4.3; p < 0.001). Contrary, the female/male rate ratio above 75 years was 2.1 (95%CI, 1.6-2.8; p < 0.001). Almost half of the injuries were soft tissue injuries, 35% were fractures and 17% were dislocations. The age-stratified incidence rates differed substantially in men and women. Fractures dominated in children up to 10 years and in adults over 60 years, soft tissue injuries in the ages between. The highest dislocation incidence rates were found in young males. A rotator cuff tear was diagnosed in 4% of the injuries. CONCLUSION: Which shoulder structures that are affected by injury vary substantially with age and gender. The shoulder injury incidence rates of young men and the elderly are high. The findings are important for the understanding of the shoulder and the diagnostic process in A&Es.

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study.

BACKGROUND: For the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection. METHODS: The study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night. DISCUSSION: The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02419040 , registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered).

The natural course of nonoperatively treated rotator cuff tears: an 8.8-year follow-up of tear anatomy and clinical outcome in 49 patients.

BACKGROUND: The natural course of nonoperatively treated rotator cuff tears is not fully understood. We explored the long-term development of tear anatomy and assessed functional outcomes. METHODS: Eighty-nine small to medium-sized full-thickness tears of the rotator cuff, all primarily treated by physiotherapy, were identified retrospectively. Twenty-three tears needed surgical treatment later on, and 17 patients were unable to meet for follow-up. The remaining 49 still unrepaired tears were re-examined after 8.8 (8.2-11.0) years with sonography. Re-examination by magnetic resonance imaging was possible for 37 patients. Shoulder function was assessed with shoulder scores. Primary outcome measures were progression of tear size, muscle atrophy, and fatty degeneration and the Constant score (CS). RESULTS: Mean tear size increased by 8.3 mm in the anterior-posterior plane (P = .001) and by 4.5 mm in the medial-lateral plane (P = .001). Increase of tear size was -5 to +9.9 mm in 33 patients, 10 to 19.9 mm in 8 patients, and ≥20 mm in 8 patients. The CS was 81 points for tear increases <20 mm and 58.5 points for increases ≥20 mm (P = .008). Muscle atrophy and fatty degeneration progressed in 18 and 15 of the 37 patients, respectively. In tears with no progression of atrophy, the CS was 82 points compared with 75.5 points in tears with progression (P = .04). CONCLUSIONS: Anatomic tear deterioration was found in the majority of patients, but it was often moderate. Large tear size increases and progression of muscle atrophy were correlated to a poorer functional outcome.

Primary rhegmatogenous retinal detachment - surgical methods and anatomical outcome.

PURPOSE: The aim of the study was to evaluate the anatomical success of surgical management of primary rhegmatogenous retinal detachment (RRD) and to compare the anatomical outcomes from different surgical techniques. METHODS: During 2012, 517 consecutive eyes (514 patients) were operated by 11 surgeons at the Department of Ophthalmology, Oslo University Hospital. Patient records were retrospectively analysed with no exclusions. Main outcome measures were primary and final anatomical success. Primary anatomical success was defined as retinal reattachment 6 months after primary surgery with reoperations excluded. Final anatomical success was defined as retinal reattachment 6 months after primary surgery with reoperations included. RESULTS: Incidence of RRD was 18.6 eyes per 100 000 person-years. The macula was detached in 50.5% of the eyes at baseline. Of 517 operated eyes, 317 (61.3%) underwent pars plana vitrectomy (PPV), 23 (4.5%) pars plana vitrectomy together with a scleral buckle (PPV-SB), 175 (33.9%) scleral buckle (SB) surgery and two (0.4%) pneumatic retinopexy (PR). Primary anatomical success was 89.0% in the PPV group, 87.0% in the PPV-SB group and 85.7% in the SB group. Final anatomical success was 98.1% in the PPV group, 100% in the PPV-SB group and 99.4% in the SB group. Factors which were correlated to the redetachment were detachment of more than 6 clock hours (p = 0.003) and visual acuity (VA) on Snellen chart <0.5 (p = 0.02) at baseline. CONCLUSION: This study showed no significant differences in the surgical success rates in the treatment of RRD between pars plana vitrectomy, scleral buckle or the combined procedure of vitrectomy and buckle. Factors which were found to be correlated to the redetachment of the retina were large detachment and low VA.

Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up.

BACKGROUND: There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears. We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed. METHODS: A single-center, pragmatic, randomized controlled study with follow-ups after six months and one, two, and five years was conducted in a secondary-care institution. One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair (n = 52) or physiotherapy (n = 51). The primary outcome measure was the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score; the physical component summary measure of the Short Form 36 Health Survey; the measurement of pain, strength, and shoulder motion; patient satisfaction; and findings from magnetic resonance imaging and sonography. Analysis was by intention to treat. RESULTS: The five-year follow-up rate was 98%. Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair. The results from primary tendon repair were superior to those from physiotherapy plus secondary repair, with between-group mean differences of 5.3 points on the Constant score (p = 0.05), 9.0 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.1 cm on a 10-cm visual analog scale for pain (p < 0.001), and 1.0 cm on a 10-cm visual analog scale for patient satisfaction (p = 0.03). In 37% of tears treated with physiotherapy only, there were increasing tear sizes on ultrasound of >5 mm, over five years, associated with an inferior outcome. CONCLUSIONS: Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment, the differences were small and may be below clinical importance. In the physiotherapy treatment group, there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair.

The natural history of asymptomatic rotator cuff tears: a three-year follow-up of fifty cases.

BACKGROUND: Little is known about the clinical and anatomic progression of asymptomatic rotator cuff tears. The purpose of our study was to assess if deterioration in rotator cuff tear anatomy would be correlated to the development of symptoms. METHODS: Fifty patients with initially asymptomatic full-thickness rotator cuff tears were followed clinically, sonographically, and by magnetic resonance imaging over three years. Changes of tear size, muscle atrophy, fatty degeneration, and condition of the long head of the biceps tendon were compared between tears that developed symptoms and those that did not. RESULTS: Eighteen of fifty tears developed symptoms during follow-up. There was a significantly larger increase (p = 0.02) in the mean tear size in the newly symptomatic group (10.6 mm) when compared with the still-asymptomatic group (3.3 mm). The rate of progressing to advanced muscle atrophy was higher (p = 0.08) in the newly symptomatic group (35% [six of seventeen subjects]) when compared with the still-asymptomatic group (12% [three of twenty-five subjects]). The rate of fatty degeneration was significantly higher (p = 0.02) in the newly symptomatic group (35% [six of seventeen subjects]) when compared with the still-asymptomatic group (4% [one of twenty-five subjects]). The rate of pathology of the long head of the biceps tendon was significantly higher (p = 0.02) in the newly symptomatic group (33% [six of eighteen subjects]) when compared with the still-asymptomatic group (6% [two of thirty-two subjects]). CONCLUSIONS: During a relatively short-term follow-up, a substantial percentage of asymptomatic rotator cuff tears became symptomatic and underwent anatomic deterioration. Increase in tear size and decrease of muscle quality were correlated to the development of symptoms. Subjects diagnosed with an asymptomatic rotator cuff tear should be informed about the natural history of the condition and follow-up with repeated imaging may be indicated to monitor tear progression.

MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects.

BACKGROUND AND PURPOSE: Why some full-thickness rotator cuff tears are symptomatic and others are asymptomatic is not understood. By comparing MRI findings in symptomatic and asymptomatic tears, we wanted to identify any tear characteristics that differed between groups. PATIENTS AND METHODS: 50 subjects with asymptomatic and 50 subjects with symptomatic full-thickness tears were examined by MRI. Tear characteristics including tear size, tear location, the condition of the long head of the biceps, atrophy, and fatty degeneration of the muscles were compared between groups. RESULTS: Single factor logistic regression analysis showed that there were statistically significant associations between symptoms and tear size exceeding 3 cm in the medial-lateral plane, positive tangent sign, and fatty degeneration exceeding grade 1 of the supraspinatus and infraspinatus muscles. INTERPRETATION: We found associations between the symptomatic status of a rotator cuff tear and MRI-derived tear characteristics. The causal relationships are unclear.

Sonography of the rotator cuff in painful shoulders performed without knowledge of clinical information: results from 58 sonographic examinations with surgical correlation.

PURPOSE: To assess the value of sonography as an isolated diagnostic test for the detection and quantification of rotator cuff tears. METHODS: Preoperative sonographic examination was performed on 58 shoulders. Key biases on sonographic interpretation such as history-taking, physical examination, or concurrent imaging examinations were excluded by way of blinding. Tears of the rotator cuff were the positive findings of interest. Assessment of tear size and localization was done sonographically, and the results were compared with operative findings. RESULTS: All 24 full-thickness tears observed at surgery had been diagnosed correctly via sonography. In 19 of 20 cases with an intact rotator cuff, preoperative sonography was negative. Thirteen of 14 partial-thickness tears were not detected via sonography; 1 was misinterpreted as a full-thickness tear. Location of the tears relative to the rotator cuff tendons was described correctly in 21 of 25 cases. For tear size measurement, the 95% range of agreement was less than +/-1 cm. CONCLUSIONS: Blinded sonographic examination is effective in the detection and quantification of full-thickness tears of the rotator cuff but lacks sensitivity in the detection of partial-thickness tears.

Diagnostic ultrasound of the shoulder--a method for experts only? Results from an orthopedic surgeon with relative inexpensive compared to operative findings.

BACKGROUND: Diagnostic ultrasound examination of the shoulder is generally considered to require long experience. We examined the results of an orthopedic surgeon with little experience of ultrasound. PATIENTS AND METHODS: A relatively inexperienced examiner performed preoperative ultrasound scanning of 79 patients with symptoms from the rotator cuff and/or the long head of the biceps muscle. Tears of the rotator cuff and rupture or dislocation of the long head of the biceps muscle were the positive findings of interest. Results were compared to operative findings. RESULTS: In 66 of 79 shoulders, ultrasonographic rotator cuff findings were confirmed at surgery (accuracy 84%). 20 of 26 full-thickness tears were diagnosed correctly. 6 of 7 partial-thickness tears were overlooked. Ultrasound was false positive in 1 case. For the long head of the biceps muscle, all 8 cases of dislocation or rupture of the tendon were diagnosed but differentiation between the two conditions was not possible in 2 cases. INTERPRETATION: Our results may encourage orthopedic surgeons to start using ultrasound as a diagnostic technique for full-thickness tears of the rotator cuff and for pathology in the long head of the biceps muscle.

[Ultrasound examination of the shoulder--a method description]. / Ultralyddiagnostikk av skulderbuen--en metodebeskrivelse.

Ultrasound examination of the shoulder in orthopaedics is not much used in Norway, but it is an established method in many institutions abroad. According to the literature, good results have been obtained with diagnostic ultrasound for demonstration of rotator cuff ruptures and abnormalities of the long tendon of the biceps muscle. In order to increase the knowledge of this diagnostic modality in Norway, we present the general principles and techniques of shoulder ultrasonography. Examples of normal and pathological ultrasound findings in the rotator cuff and long tendon of the biceps muscle are given.