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IntroductionDupuytren’s contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques.Methods and analysisWe planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I–III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient’s trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed.Ethics and disseminationThe protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registration number NCT03192020; Pre-results.

In a randomized trial in patients with moderate Dupuytren’s contracture, collagenase was not noninferior to limited fasciectomy with respect to the Patient Evaluation Measure score at 1 year after treatment.

Burn patients experience severe pain when undergoing rehabilitation after skin grafting, which negatively affects their recovery. Traditional analgesic methods (such as opioids) have the risk of addictiveness and side effects. Nitrous oxide, which has rapid analgesic and sedative effects, is commonly used for conscious analgesia. The purpose of this study was to determine whether diluted nitrous oxide reduces pain compared to Placebo(oxygen) during rehabilitation after burn surgery. This single-center, randomized, double-blind, and controlled trial will enroll 80 patients. Patients ≥ 18 years of age who underwent rehabilitation 1 month after burn surgery with acute pain (VAS ≥ 4) were included. The main exclusion criteria included: pulmonary disease (pulmonary embolism, pneumothorax), intestinal obstruction, etc. Patients were randomly assigned in a 1: 1 ratio to intervention (A) and control (B) groups. Doctors, therapists, patients, and data collectors were unaware of the assignment outcomes. Rehabilitation will be performed by a therapist. The nurse performing the intervention handed the envelope with the patient code and the A or B assignment to the physician. Group A will receive diluted nitrous oxide inhalation plus conventional therapy (without analgesics) 30 minutes once daily for 4 weeks, and Group B will receive oxygen plus conventional therapy (without analgesics) under the same conditions. Assessments will be performed before the intervention (T0), 2 minutes (T1) and 5 minutes (T2) after the start of the intervention, and 5 minutes (T3) after the start of the intervention. The primary outcome was pain score. Secondary outcomes included vital signs, side effects, quality of life score, scar score, need for adjuvant analgesia, therapist and patient satisfaction, and willingness to receive the same gas again. If the experimental results show that diluted nitrous oxide can bring good analgesic effects without serious side effects, it can improve patients' compliance with rehabilitation treatment and quality of life, and it is even widely implemented in hospitals and rehabilitation institutions.

Background Dupuytren’s contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment; however, recent studies have indicated that an alternative to surgery—collagenase clostridium histolyticum (collagenase)—is better than a placebo in the treatment of Dupuytren’s contracture. There is however no robust randomised controlled trial that provides a definitive answer on the clinical effectiveness of collagenase compared with limited fasciectomy surgery. Dupuytren’s intervention surgery vs collagenase trial (DISC) trial was therefore designed to fill this evidence gap. Methods/design The DISC trial is a multi-centre pragmatic two-arm parallel-group, randomised controlled trial. Participants will be assigned 1:1 to receive either collagenase injection or surgery (limited fasciectomy). We aim to recruit 710 adult participants with Dupuytren’s contracture. Potential participants will be identified in primary and secondary care, screened by a delegated clinician and if eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported patient evaluation measure assessed 1 year after treatment. Secondary outcome measures include the Unité Rhumatologique des Affections de la Main Scale, the Michigan Hand Questionnaire, EQ-5D-5L, resource use, further procedures, complications, recurrence, total active movement and extension deficit, and time to return to function. Given the limited evidence comparing recurrence rates following collagenase injection and limited fasciectomy, and the importance of a return to function as soon as possible for patients, the associated measures for each will be prioritised to allow treatment effectiveness in the context of these key elements to be assessed. An economic evaluation will assess the cost-effectiveness of treatments, and a qualitative sub-study will assess participants’ experiences and preferences of the treatments. Discussion The DISC trial is the first randomised controlled trial, to our knowledge, to investigate the clinical and cost-effectiveness of collagenase compared to limited fasciectomy surgery for patients with Dupuytren’s contracture. Trial registration Clinical.Trials.gov ISRCTN18254597 . Registered on April 11, 2017.

Background Capsular contracture is the most common complication of breast augmentation and reconstruction. It occurs in up to 45% of patients and is theorized to occur secondary to an immune reaction. It can lead to pain, dissatisfaction with aesthetic outcomes, and reoperation. The gold standard for management is capsulectomy. Prior similar studies are limited by narrow inclusion criteria, single-surgeon analysis, small sample size, or univariate analysis. The goal of the following study is to prospectively identify possible risk factors for capsular contracture using a national database. Methods A retrospective review was conducted utilizing the National Surgical Quality Improvement Program (NSQIP) Database of prospectively collected data of patients undergoing periprosthetic and/or total capsulectomy for capsular contracture from 2013 to 2016. Odds ratios (OR) with 95% confidence intervals (CI) were calculated for variables using a multivariable binary logistic regression model. Results A total of 6547 patients underwent reconstructive or augmentation mammaplasty with a prosthetic implant, out of which 2543 (39%) underwent capsulectomy. Capsular contracture was more likely in older (OR: 1.10, 95% CI: 1.09–1.10, p <.001), overweight (OR: 1.12, 95% CI: 1.10–1.13, p <.001), and cancer patients (OR: 7.71, 95% CI: 2.22–28.8, p =0.001). Wound infection was associated with capsulectomy (OR: 6.69, 95% CI: 1.74–25.8, p <.001). Conclusion: These identified risk factors should be comprehensively addressed with patients during the informed consent process before breast augmentation or reconstruction with implants. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background Acquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework. Methods Nursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents’ data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms. Results Seven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention ( n  = 64) or control group ( n  = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents’ disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups. Conclusion Our data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention. Trial registration German clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016.

Background Dupuytren’s contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contracture. Methods/design HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren’s contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren’s on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients’ experiences of trial participation and the interventions. Discussion This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren’s contractures is feasible, and if so will provide data to inform its design and successful conduct. Trial registration International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015.

In this randomized, double-blind trial involving 308 patients with Dupuytren's contractures, injections of collagenase clostridium histolyticum were more effective than placebo injections in reducing contractures and restoring range of motion. Adverse effects included tendon rupture in two patients and localized pain and swelling in most patients. In patients with Dupuytren's contractures, injections of collagenase clostridium histolyticum were more effective than placebo injections in reducing contractures and restoring range of motion. Dupuytren's disease, a progressive genetic disorder of pathologic collagen production and deposition, begins with palpable nodules in the palm. 1 , 2 Later, pathologic collagen cords form, extend longitudinally, thicken, and shorten, causing flexion contractures of the joints, which can severely limit hand function. Contractures typically affect the metacarpophalangeal joint, the proximal interphalangeal joint, or both. The ring and little fingers are most commonly affected. Dupuytren's disease occurs in all racial and ethnic groups, but the incidence of this disease is highest among people of northern European descent. 3 – 5 The estimated global prevalence among whites is 3 to 6%. 3 , 6 Dupuytren's disease . . .

BackgroundA large number of clinical studies have suggested that acellular dermal matrix (ADM) can decrease the incidence of capsular contracture in implant-based breast reconstruction. Yet, there is currently no high-level epidemiological evidence to prove this. The goal of this meta-analysis was to clarify the efficacy of ADM in capsular contracture, and provide a reference value for plastic surgeons.MethodsWe systematically performed a search on PubMed, EMBASE, and the Cochrane Library to identify eligible studies from inception up to October 1, 2019. A random-effects model was used to obtain a pooled incidence rate. We conducted subgroup analysis according to geographic region, type of ADM, body mass index (BMI), duration of follow-up, and proportion of participants who have received radiotherapy.ResultsA total of 18 studies involving 2941 cases were included. Overall, the pooled incidence rate of capsular contracture was 2.4% (95% CI 1.2–3.9%). The results from subgroup analyses indicated an even lower incidence in North America (1.6%, 95% CI 0.5–3.3%) and in human-derived ADM (HADM) (1.2%, 95% CI 0.2–3.0%). In addition, the results showed that the patients with BMI < 24, or who have received radiotherapy, were more prone to capsular contracture.ConclusionThe application of ADM can effectively reduce the incidence of capsular contracture in implant-based breast reconstruction. And we infer that it might also apply to breast augmentation. However, additional high-quality trials are warranted to corroborate the findings of this meta-analysis.Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

IntroductionIn hip osteoarthritis, hip flexion contracture can severely alter the patient’s alignment, and, therefore, affect the patient’s quality of life (QOL). Hip contracture is not well-studied, partly because of the difficulties of its diagnosis. The aim of this study was to propose a quantitative definition of hip flexion contracture, and to analyse sagittal alignment in these patients compared to non-contracture ones, before and 12 months after total hip arthroplasty (THA).Materials and methodsConsecutive patients with hip arthrosis and an indication for THA were included (N = 123). Sagittal full-body radiographs were acquired in free standing position and in extension. QOL questionnaires were administered before and after surgery. Spinopelvic parameters were measured, including the pelvic–femur angle (PFA). Patients with low pelvic incidence (< 45°) were included in the hip contracture group if PFA > 5°, or PFA > -5° when pelvic incidence ≥ 45°.Results29% of patients were in the hip flexion contracture group, and they showed lower pelvic tilt than the no-contracture group (p < 0.001), larger lumbar lordosis (LL) and smaller PI-LL (p < 0.001), as well as a forward position of the head. 16% of patients still had hip contracture 12-months postop. Contracture patients showed higher QOL scores after surgery.ConclusionsThe proposed method to diagnose hip contracture group allowed to define a group of patients who showed a specific pattern of sagittal spinopelvic alignment. These patients improved their alignment and quality of life postoperatively, but their hip mobility was not always restored. Diagnosing these patients is a first step toward the development of more specific surgical approaches, aiming to improve their surgical outcome.