Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function. Two treatments for Dupuytren's contractures are widely used within the National Health Service (NHS) in the UK: removal of the contractures via surgery (limited fasciectomy) and division of the contractures via a needle inserted through the skin (needle fasciotomy). This study aims to establish the clinical and cost-effectiveness of needle fasciotomy (NF) versus limited fasciectomy (LF) for the treatment of DC in the NHS, in terms of patient-reported hand function and resource utilisation. METHODS/DESIGN: Hand-2 is a national multi-centre, two-arm, parallel-group randomised, non-inferiority trial. Patients will be eligible to join the trial if they are aged 18 years or older, have at least one previously untreated finger with a well-defined Dupuytren's contracture of 30° or greater that causes functional problems and is suitable for treatment with either LF or NF. Patients with a contracture of the distal interphalangeal joint only are ineligible. Eligible consenting patients will be randomised 1:1 to receive either NF or LF and will be followed up for 24 months post-treatment. A QuinteT Recruitment Intervention will be used to optimise recruitment. The primary outcome measure is the participant-reported assessment of hand function, assessed by the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes include other patient-reported measures, loss of finger movement, and cost-effectiveness, reported over the 24-month post-treatment. Embedded qualitative research will explore patient experiences and acceptability of treatment at 2 years post-surgery. DISCUSSION: This study will determine whether treatment with needle fasciotomy is non-inferior to limited fasciectomy in terms of patient-reported hand function at 12 months post-treatment. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy ISRCTN12525655. Registered on 18th September 2020.

Development of a Patient-Based Goniometric System for the Assessment of Contracture Conditions in Dupuytren's Disease.

BACKGROUND: Treatment outcomes of Dupuytren's disease depend largely on degree of contracture and biological severity. Longitudinal assessment of each is crucial for effective care and long-term outcome assessment. Ideally, each Dupuytren's patient should have ongoing interval evaluations. Because of the large number of Dupuytren's patients, it would be impractical and costly for health care professionals to examine every patient in person on a regular basis. Patient-based evaluations might provide a useful and cost-effective alternative to office-based examination. METHODS: Finger goniometry is the standard metric for office-based evaluation of Dupuytren's disease. This study's goal was to develop a new patient-reported goniometric system. The authors developed a completely Web-based goniometric software for patients to use without supervision and without undue effort or cost. They then evaluated the validity and precision of the core measurement system and the reliability of its patient-based application. RESULTS: With a correlation of 0.992 (p < 0.01), a mean deviation of -0.25 degree, and a standard deviation of 2.74 degrees in patient-based application, the authors found their goniometric software to be comparable to practitioner-based, conventional goniometry. The authors believe patient-based goniometry to be a sufficiently accurate, valid, and reliable approach for longitudinal clinical assessment of Dupuytren's disease. CONCLUSIONS: Patient-based goniometric approaches have great potential for inexpensive, accurate, and accessible longitudinal assessment of the large population of Dupuytren's patients. Such approaches could help to substantially improve overall care of Dupuytren's disease through early diagnosis and timely treatment. In addition, being able to collect reliable patient data on a regular basis and on a larger scale could help improve understanding of the natural history of Dupuytren's disease. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, I.

DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

INTRODUCTION: Dupuytren'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 ANALYSIS: We 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 DISSEMINATION: The 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.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): study protocol for a randomised controlled trial.

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.

Collagenase clostridium histolyticum in Dupuytren's contracture: a systematic review.

INTRODUCTION: In the last few years, the use of collagenase clostridium histolyticum for management of Dupuytren's contracture has increased. The procedure of enzymatic fasciectomy has become popular because it is non-invasive, safe and fast to perform. SOURCES OF DATA: A systematic search was performed on Medline (PubMed), Web of Science and Scopus databases using the combined keywords 'Dupuytren collagenase' and 'Dupuytren clostridium histolyticum'. Forty-three studies were identified. The quality of the studies was assessed using the Coleman Methodological Score. AREAS OF AGREEMENT: The use of collagenase clostridium histolyticum provides better outcomes in patients with mild-moderate joint contracture, with lower complications and side effects than open fasciectomy. Manipulation can be performed 2-7 days after the injection. The use of collagenase is cost-effective. AREAS OF CONTROVERSY: Most of the studies did not report patient-related outcomes. The role of dynamic splint has to be investigated with randomized clinical trials. GROWING POINTS: The shorter recovery time and the low incidence of serious or major adverse effects are the main advantages of this new technology. AREAS TIMELY FOR DEVELOPING RESEARCH: There is a need to perform studies with longer follow-up because the recurrence rate seems to increase with time. Further investigations are necessary to assess whether it is safe and effective to inject two or more cords at the same time.

[Assessment of functional activity of phagocytic system in patients suffered from Dupuytren's contracture with hepatic fibrosis].

Dupuytren's contracture--a pathology that should not be seen as an isolated lesion tendon-aponeurotic structures of the palmar surface of the hand, but as a disease that requires careful research and a comprehensive, differentiated approach to treatment. The aim of the study was to investigate the functional activity of the phagocytic system of Dupuytren's contracture patients with chronic hepatitis and liver fibrosis in liquidators of the CHNPP accident consequences. The resulting study 188 patients aged 45-65 years showed the correlation of the data of the functional activity of phagocytic system with degree of liver fibrosis, thus objectively assess the patient's condition and make the appropriate correction in the diagnostic criteria as well as in medical and rehabilitative programs.

[An assessment of the influence of the severity of Dupuytren's contracture on the dexterity of the hand before and after surgery]. / Ocena wplywu ciezkosci przykurczu Dupuytrena na sprawnosc reki przed i po leczeniu operacyjnym.

It seems to evident that deformation of the hand as a result of Dupuytren's contracture should cause weakness and overall functional impairment of the hand, and an increase of range of motion of the fingers as a result of the operation should effect in improvement of these parameters. The objective of this study was to investigate the effect of extension loss of fingers, number of fingers involved and age of the patients on the power and dexterity of the hand, as well as influence of the age of the patients and recovery of extension of the fingers on the power and dexterity of the hand after surgery for Dupuytren's contracture. 54 patients in an age range 32-83 years (mean 60) with the disease lasting av. 5 years underwent subtotal fasciectomy. Total extension loss of the fingers and total grip strength were measured and dexterity of the hand was assessed with DASH questionnaire prior to surgery. Patients were followed-up for 1 year and assessments were repeated at 1, 3 and finally at 12 months. Median values of measured variables at presentation were as follows: extension loss 80 degrees, total grip strength 41 kG, and DASH score 54. At 12 months median extension loss decreased to 10 degrees (stat. sign.), DASH score to 32 (stat. sign. improvement of dexterity) and grip strength decreased slightly to 40 kG. An analysis of the relationship between the variables showed that severity of the contracture (expressed as an extension loss) had no effect on dexterity of the hand but had significant influence on deterioration of the total grip strength. Number of fingers involved did affect neither dexterity nor power of the hand. Age of the patients did not influence subjective feeling of dexterity of the hand, however, older patients experienced lesser functional benefit from the operation, than younger patients. An increase of extension of the fingers following surgery had significant beneficial effect on subjective improvement of the dexterity of the hand, but had not effect on the increase of power of the hand.

[The assessment of autonomic nervous system function in women with degenerative pathology of the hand]. / Otsenka funktsional'nog sostoianiia vegetativnoi nervnoi sistemy u zhenshchin s degenerativnoi patologiei kisti.

An all-round study was made of the function of the vegetative tone, responsiveness and supply of the parts of the autonomic nervous system in women with degenerative hand pathology. As compared with the control group, serious disorders were detected in all the parts and properties of the system. The conclusion is made that these mechanisms are implicated in the development of the disease group under study.