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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.

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 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 Injuries and resulting stiffness around joints, especially the elbow, have huge psychological effects by reducing quality of life through interference with normal daily activities such as feeding, dressing, grooming, and reaching for objects. Over the last several years and through numerous research results, the myofibroblast-mast cell-neuropeptide axis of fibrosis had been implicated in post-traumatic joint contractures. Pre-clinical models and a pilot randomized clinical trial (RCT) demonstrated the feasibility and safety of using Ketotifen Fumarate (KF), a mast cell stabilizer to prevent elbow joint contractures. This study aims to evaluate the efficacy of KF in reducing joint contracture severity in adult participants with operately treated elbow fractures and/or dislocations. Methods/design A Phase III randomized, controlled, double-blinded multicentre trial with 3 parallel groups (KF 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks). The study population consist of adults who are at least 18 years old and within 7 days of injury. The types of injuries are distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2 U1 and/or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included). A stratified randomization scheme by hospital site will be used to assign eligible participants to the groups in a 1:1:1 ratio. The primary outcome is change in elbow flexion-extension range of motion (ROM) arc from baseline to 12 weeks post-randomization. The secondary outcomes are changes in ROM from baseline to 6, 24 & 52 weeks, PROMs at 2, 6, 12, 24 & 52 weeks and impact of KF on safety including serious adverse events and fracture healing. Descriptive analysis for all outcomes will be reported and ANCOVA be used to evaluate the efficacy KF over lactose placebo with respect to the improvement in ROM. Discussion The results of this study will provide evidence for the use of KF in reducing post-traumatic joint contractures and improving quality of life after joint injuries. Trial registration This study was prospectively registered (July 10, 2018) with ClinicalTrials.gov reference: NCT03582176 .

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.

Background To evaluate the effects and side-effects of serial sub-conjunctival injections of 5-fluorouracil (5-FU) in early postoperative period for recurrent anophthalmic contracted socket. Methods Retrospective comparative case series at tertiary eye care centre including fifteen adult patients with features of postoperative recurrent socket contraction after buccal mucosal graft. Group A comprised eight patients treated with 10 mg weekly sub-conjunctival injection of 5–FU in the fornices. Group B comprised seven patients taken as control. Main outcome measures were: superior fornix depth (SFD), inferior fornix depth (IFD), and socket volume (SV) at 6 months follow up. Patients were re-evaluated clinically for recurrence at last follow-up. Results The mean ± SD values in group A versus group B were as follows: 10 ± 1.6 mm vs 5.1 ± 0.9 mm ( p  < 0.005) for SFD, 6.7 ± 1.5 mm vs 3.5 ± 0.5 mm ( p  = 0.02) for IFD; and 2 ± 0.55 ml versus 0.27 ± 0.06 ml ( p  = 0.005) for SV at 6 months. There was significant improvement in depth of fornices and volume of socket in seven patients in group A. One patient in group A did not benefit from 5-FU treatment. The beneficial effects of 5-FU were observed when first injection was given within 4 weeks after socket reconstruction. There was no recurrence (in six cases) and no side-effects seen in group A at final follow-up of 18.2 (12–24) months. Conclusions Weekly injections of 5-FU are effective for stopping the progression of recurrent contracted socket following primary reconstructive surgery. It provides early rehabilitation, and avoids repetitive surgery.

The purpose of the study was to explore the relationship between preoperative flexion contracture (FC) and self-reported disability in patients undergoing surgical release by fasciectomy or dermofasciectomy. The study design used was a prospective observational study: Dupuytren’s disease (DD) is a fibroproliferative disorder of the palmar fascia and may lead to functional deficits requiring surgical intervention. Outcomes are usually reported using digital range of motion although recent studies have also included patient-rated outcome measures with the extensively validated Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire commonly used. One hundred fifty-four patients consecutively enrolled in a prospective randomized trial were assessed before surgery for active range of movement using goniometry and self-reported functioning using DASH questionnaire. The small finger was affected in 69% of patients with a mean FC of 77.8 degrees (standard deviation = 43.5°). The mean DASH score was 16 points (range, 0–62). The correlation between severity of FC in all four fingers and DASH was weak ( r = 0.264, p = 0.001). At individual digital level, the correlation between FC and DASH was weak in the index ( r = 0.26), middle ( r = 0.28), and ring ( r = 0.21) fingers but almost absent in the small finger ( r = 0.07). These results show that the relationship between severity of FC and functional disability measured by the DASH questionnaire appear to be very weak or even absent. Level of evidence: Level III prospective cohort study.

Dupuytren Disease (DD) is a chronic progressive disease that can cause disabling hand deformities. The most common treatments have either high complication rates or high early recurrence rates. Dupuytren lacks a staging biomarker profile to inform the development of preventive therapeutics to improve long-term outcomes. This multi-omic study aimed to create a DD blood proteomic biomarker profile by comparing DD plasma with that of a healthy control group. We measured circulating collagen metabolism peptides and found normal Collagen I synthesis but impaired Collagen I degradation in DD. We measured 6995 serum protein aptamers and identified 68 proteins that showed statistically significant differences compared with the control group. We developed two Diagnostic Proteomic Risk Scores (DPRS) based on hypothesis-free and hypothesis-based analyses. In independent data, our hypothesis-free and hypothesis-based DPRS distinguished Dupuytren from control subjects with accuracies of 76.5% and 70.6%, respectively. Our hypothesis-based DPRS also distinguished DD subjects with different disease progression rates by age at their first corrective procedure (p = 0.0018). This pilot study is the first to provide evidence to suggest that Collagen I accumulation in DD results from impaired degradation rather than increased collagen synthesis. It also describes novel DPRS that have potential use as diagnostic and staging biomarker panels for Dupuytren disease.

One of the major determinants of Dupyutren disease (DD) treatment efficacy is recurrence of the contracture. Unfortunately, lack of agreement in the literature on what constitutes recurrence makes it nearly impossible to compare the multiple treatments alternatives available today. The aim of this study is to bring an unbiased pool of experts to agree upon what would be considered a recurrence of DD after treatment; and from that consensus establish a much-needed definition for DD recurrence. To reach an expert consensus on the definition of recurrence we used the Delphi method and invited 43 Dupuytren's research and treatment experts from 10 countries to participate by answering a series of questionnaire rounds. After each round the answers were analyzed and the experts received a feedback report with another questionnaire round to further hone in of the definition. We defined consensus when at least 70% of the experts agreed on a topic. Twenty-one experts agreed to participate in this study. After four consensus rounds, we agreed that DD recurrence should be defined as \"more than 20 degrees of contracture recurrence in any treated joint at one year post-treatment compared to six weeks post-treatment\". In addition, \"recurrence should be reported individually for every treated joint\" and afterwards measurements should be repeated and reported yearly. This study provides the most comprehensive to date definition of what should be considered recurrence of DD. These standardized criteria should allow us to better evaluate the many treatment alternatives.

This case is a 37-year-old man with diffuse primary synovial chondromatosis of the elbow, with associated ulnar nerve compression and flexion contracture at the elbow. An open synovectomy with removal of loose bodies and an ulnar nerve decompression with anterior subcutaneous transposition were performed. Postoperatively, the patient’s elbow mobility and nerve compression symptoms improved steadily, which significantly improved his function. Primary synovial chondromatosis of the elbow is a rare disease that can result in pain, swelling, decreased range of motion, and mechanical symptoms. Treatment usually involves synovectomy and removal of loose bodies to address patients’ pain and joint motion.