All patients will be treated by a certified (orthopaedic) trauma surgeon with experience in ORIF of distalradiusfractures and wrist arthroscopy. In both groups ORIF of the distalradius fracture will be similar. The interven- tion group will be treated with wrist arthroscopy follow- ing ORIF. A delay of at least five days before performing arthroscopy is mandatory to enable visualisation due to the organisation of the hematoma. The operation has to be performed within three weeks after the initial trauma. Antibiotic prophylaxis (Cefazoline, 1000 mg i.v.) is given preoperatively, according to the current standard. The volar approach according to Henry will be used . This entails an incision between the radial artery and the tendon of the flexor carpi radialis. The pronator quadratus muscle from will be detached from its distal and lateral side and lifted for optimal exposure to the fracture site. After the fracture site is revealed, the frac- ture will be debrided, reduced and fixated with an ap- propriate volar locking plate. The type and brand of the plate are at the discretion of the treating surgeon. When a dorsal approach is deemed necessary the distalradius will be approached through the third dorsal extensor tendon compartment, without opening the dorsal cap- sule. Fluoroscopic images are obtained to evaluate the quality of articular reduction. Wrist arthroscopy will be
Each patient will be assigned a unique trial identification number (TIN) that will be matched with the patient’s identification number (ID). The matching key will be stored in a locked office at Tampere University Hospital, Finland, and the identification of each patient will only be possible after retrieving the matching key. Through- out the trial, the research data will be handled only with a TIN. The research data will be saved to a database with an online patient management program (PMP) located on a secure research server. The research data saved to the server will contain only anonymous TINs with a set of numbers acquired from the questionnaires, i.e., each question will be answered with a number. This will en- sure the anonymity of each individual patient and that the identity of the patient will remain secret should the server data be revealed to third-parties.
A few limitations of our study should be noted. Firstly, this was a retrospective study. Secondly, there was no randomisation of treatment groups. Thirdly, only short- term outcomes (12 months) were measured in this study. Although the sample sizes in the ORIF and nonoperative groups (32 and 28, respectively) after the criteria were applied were by no means small, a larger—ideally prospective and randomised—trial looking into both the short- and long-term outcomes will provide more infor- mation and a higher level of evidence. One notable omis- sion from our radiographic assessment was radiographic changes of osteoarthritis. This was due to the perceived short duration (12 months) from injury when radiographic assessment was performed in our study. In addition, early radiographic changes do not always progress and result in clinically relevant post-traumatic osteoarthritis [19, 20].
A recent randomisedcontrolledtrial by Arora et al. compared open reduction and internal fixation with a volar locking plate with closed reduction and plaster im- mobilisation. They included patients of 65 years and older who had suffered all types of displaced distalradius frac- tures with inadequate reduction or redisplacement . The operativetreatment group showed better wrist func- tion in the early post-operative period. However, at six and twelve months there were no significant differences in wrist function between treatment groups. At all times, grip strength was significantly better in the operative group. These results are consistent with a previous retrospective cohort study among elderly patients conducted by Arora et al. as well . Future studies compare the quality of
Methods/design: This is a single-centre, prospective, randomisedcontrolledtrial that aims to randomise 154 participants with an unstable ankle fracture to ‘ non-fixation ’ ( n = 77) or ‘ fixation ’ (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed ‘ well-reduced ’ , with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications.
AE: adverse event; ANCOVA: analysis of covariance; AO: Arbeitsgemeinschaft Osteosynthese; BMI: Body-Mass-Index; CRC: closed reduction and casting; CRPS I: chronic regional pain syndrome type I; CRF: case report form; DASH score: disability of the arm, shoulder and hand score; DSMB: data safety monitoring board; GCP: good clinical practice; IQOLA: International Quality of Life Assessment; ITT: intention to treat; IRB: institutional review board; MCRD: minimally clinically relevant difference; MCID: minimum clinically important difference; NSAID: non-steroidal anti-inflammatory drug; ORCHID: open reduction and internal fixation versus casting for highly comminuted intra- articularfractures of the distalradius; PCS: physical component score; ORIF: open reduction and internal fixation; RCT: randomisedcontrolledtrial; ROM: range of motion; SAE: serious adverse event; SF-36: ShortForm 36 score; SF- 36-PCS: ShortForm 36 - Physical Component Score.
All patients were treated on an outpatient basis with reduction of fractures by manipulation with traction and counter-traction under anaesthesia by blockage of the brachial plexus or under general anaesthesia. Four previ- ously designated surgeons with proven familiarity with both surgical techniques took part in the study. The sur- gical instruments needed for application of both treat- ment techniques were always available in the surgical room used for each operation. The technique to be used for each patient was only revealed intraoperatively, after radiological verification of fracture reducibility. At that time, the opaque sealed envelope was opened by inde- pendent person to reveal the treatment technique to be used. None of the patients underwent any specific treat- ment for associated fractures of the ulnar styloid.
The value of the study includes all participants will be reduced in the main operating room under general intravenous anesthesia and with the aid of radioscopy which will allow better control of the pain and max- imum quality in the reduction. All reductions and immobilizations will be performed by a single researcher, specialist in hand surgery. The follow up during the immobilization period will be weekly, with radiographic documentation, which allows the early identification of the reduction loss. This is the only trial to apply DASH questionnaire at the beginning and end of immobilization period (2 and 6 weeks) to compare the groups. Pain in the wrist, elbow and shoulder will be measured separately in all visits to verify the influence of immobilization on the elbow and shoulder joints. Adults of all ages will be evalu- ated, it is known that the DRF in the elderly has different behavior and prognosis when compared to the young [35–38]. Randomization will equalize the distribution homogeneously between the groups, allowing the sample to be faithful to the population.
Fractures of the distalradius are common [1–3]. The increasing incidence of these injuries may be attributed to an aging population (osteoporotic fractures) and the growing participation in outdoor pursuits (higher energy fractures) [4, 5]. Whereas a large number of these fractures are managed non-operatively, the number of patients who undergo surgical management is considerable. Over the past 30 years, the surgical treatment of distalradius frac- ture has shifted from cast immobilization to numerous surgical options such as the use of external fixation and volar locking plates [6–9]. There are distinctive differences in these two surgical techniques and postoperative reha- bilitation protocols. Previously some authors have com- pared volar locked plating with external fixation, but there is still insufficient evidence regarding which gives the best outcome [10–14].
All of the surgeons who took part were considered to be experts by their peers. They are the surgeons to whom patients with calcaneal fractures are referred from across the United Kingdom. It is possible that a surgeon with an extremely specialised practice, and with a high volume of this type of surgery, could achieve a better outcome. We have no evidence to support this, and such a trial could not be performed in the United Kingdom. This study provides a pragmatic result for the UK National Health Service, which reflects current surgical practice, case mix, and organisation of services in the United Kingdom. Recruitment rate was 30% among eligible patients, which is at least as high as has been achieved in other surgical trials of operative compared with non-operative care. We are confident that our result is generalisable because those who agreed and those who declined to participate were similar in all factors that we found to be associated with variation in outcome. The follow-up rate was 95% for the primary outcome measure, giving us confidence in our estimate of effect. There was no significant change in this estimate between an intention to treat analysis and a per protocol analysis, indicating that the small crossover rate (5%) did not influence our results.
Methods/Design: This multicentre randomisedcontrolledtrial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articulardistalradius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study.
The principal investigator (PI) or authorised member of the team will have a written procedure for requesting randomisation codes for rapidly identifying a blinded IMP in an emergency. Breaking the blind of a trial sub- ject will be at the discretion of the PI, when clinically indicated for the safety of the patient or in the event of a SUSAR. If the patient needs to be unblinded we will refer to the unblinding SOP for complete details of the proce- dures to be followed. The master randomisation codes will be kept by the clinical trial pharmacist and the PI. Unblinding will be performed by the senior clinician/ pharmacist when the criteria for a serious adverse event (SAE)/SUSAR have been met, and there is a necessity for the PI or treating healthcare professional to know which treatment the patient is receiving to ensure that the pa- tient receives appropriate urgent safety measures.
The use of fixed angle devices such as the condylar blade plate and the Dynamic Condylar Screw (DCS) requires certain amount of bone stock which limits their use in comminuted fractures. This led to development of condylar buttress plate for comminuted femoral fractures. However, with standard condylar buttress plate, these fractures often have a tendency to fall into a varus collapse because of toggle at the screw- plate interface. Retrograde nails have proved to be very useful in extra-articular and partial articulardistal femur fractures, but fixation of comminuted articularfractures is still a grey area with such an implant. To address these issues, locking condylar plate was designed. A locking condylar plate decreases screw- plate toggle and provides more stable fixation which is one of the key factor in the successful treatment of these fractures. These devices create a fixed angle at each screw hole where the individual screw head is secured to the plate by a locking mechanism [3-5]. Since,
As the confidence intervals exclude the minimum clinically important difference for the patient rated wrist evaluation (PRWE), we conclude that any difference in functional scores between treatment groups is unlikely to be important to patients. Furthermore, secondary clinical outcomes show that there is no clinically relevant difference between the groups in terms of health related quality of life or the risk of complications. There was a borderline significant difference in the disabilities of arm, shoulder and hand (DASH) at one time point (12 months) in favour of the locking plate, but this was well below the minimum clinically important difference. 23 Kirschner wire fixation,
A small randomisedcontrolledtrial was recently pub- lished ; it included 60 participants with an acute, iso- lated middle-third clavicle fracture. The authors compared the broad arm sling with the figure-of-eight bandage; their outcome measures were pain, Constant and American Shoulder and Elbow Surgeons scores and degree of radio- graphic union. The study concluded that both techniques provided acceptable functional and radiological outcomes for treating clavicle fractures. However, the broad arm sling was significantly more comfortable in the first 3 days of treatment. One weakness of that study was the small sample size and the additional loss of patients in the final follow-up period (two patients in the broad arm sling group and seven patients in the figure-of-eight bandage group), which may have affected the results, since the sampling loss was greater in the figure-of-eight bandage group. The study had other sources of bias. First, the study design did not permit blinding of participants, orthopaedic surgeons and outcome assessors; although failure of blinding can have a serious effect on study outcomes, the authors were unable to perform it. Secondly, the function outcomes (Constant and American Shoulder and Elbow Surgeons scores) were not validated for use in a number of settings (mainly Constant score) and these scores may not be specific for use as an outcome in clavicle fractures .
An economic evaluation will estimate the incremental costs and consequences of the intervention versus control arm. The primary outcome for the cost-effectiveness analysis will be the incremental cost per additional responder, with re- sponse defined as a clinically important improvement of 30% on a 0–10 NRS one week post-screening for those with moderate-severe (≥5 NRS) worst pain). The incremen- tal cost per additional quality adjusted life years (QALY) will be the secondary outcome. Utility scores will be derived from the EORTC QLQ-C15-PAL and 5 additional items from the QLQ-C30 (mapped from QLQ-Utility ) and index values for carers from the CES. Survey responses will be linked to health service utilisation data accessed through the Centre for Health Record Linkage (CHeReL) and from Commonwealth datasets (Medicare Benefits Scheme (MBS); Pharmaceutical Benefits Scheme [PBS]) and hospital records. Variables will include: Australian Refined Diagnosis Related Groups (ARDRG) code; number of hospitalisations; length of hospital stays; number of emergency department, outpatient, psychology/psychiatry and general practitioner (GP) visits; health insurance status; medication usage. Costs of the intervention will relate to the screening systems im- plemented at each service, materials for training, and staff time spent on attending training and screening, assessing and managing cancer pain. As economic data may be skewed, confidence intervals will be estimated with boot- strap methods . Sensitivity analysis will examine the effect of assumptions and determine which cost compo- nents drive the results.
To study the changes in the rates of different surgical techniques of the distalradiusfractures over time we studied all persons 50 years of age and older in Finland between the 1 st of January 1998 and 31 st of December 2016. The distalradius fracture surgery data was ob- tained from the Finnish National Hospital Discharge Register (NHDR), which is an electronic hospital data registry containing variables such as personal identifica- tion number, sex, domicile, external cause of injury, diagnoses, and all surgical procedures performed during the hospital stay. The NHDR is mandatory for all hospi- tals in Finland including all private and public hospitals. The NHDR has been widely used in epidemiological re- search and the quality of the register is reportedly excel- lent [20, 21]. As a register-based blinded analysis, the study did not have identifiable individual participants and thus neither informed consent nor ethics approval was needed.
Extralesional excision is performed with minimal mar- gins, and absorbable monofilament sutures or perman- ent monofilament sutures are used for closure (Monocryl™, Ethilon™, Ethicon Inc, Somerville, NJ, USA). Surgery is performed by either surgical residents who have three years minimum experience, or by plastic sur- geons. This standardised surgical procedure is not de- manding, and we expect no learning curve. Many different surgeons (>20) reflect usual clinical practice in keloid treatment. After 2 weeks, an injection of triamcin- olone acetonide 40 mg/ml is given in the newly formed scar. The injections can be repeated at 8 and 12 weeks postoperatively.
Fit with the target group: To make the program suitable for a target group of youth with complex problems, the current program contains less verbal and more practical and visual elements (e.g. pictograms, video clips), the text and layout of treatment materials were simplified, and efforts were made to optimize generalizability to daily life (e.g. use of a personal implementation plan, inclusion of parents and supervisors in home work exercises, and more attention to personal experiences of youth). For youth with MID, a parallel version of the program was created, following the suggestions of the expert group and Didden : (1) the MID version contains less verbal and more visual and practical exercises than the non-MID version, and language is simplified; (2) in the MID version, ado- lescents receive more support from social workers (e.g. help in homework, help in detecting inaccurate thoughts and challenging their thoughts) than in the non-MID version in order to adapt to their cognitive ability and to optimize generalizability to daily life; (3) the trained skills are taught through smaller sub- steps; and (4) techniques that require higher-order cognitive reasoning (e.g. reasoning about a hypothet- ical situation; reasoning about other people’s
Lots of articles [27–36] compared the clinical out- comes of intra-articular PRP injection with other conser- vative treatment methods (including oral NSAIDs, HA, and corticosteroids injection), and there are different re- sults among these comparisons. The American Academy of Orthopaedic Surgeons Clinical Guidelines suggested that HA injection is not recommended for the treatment of KOA, while PRP injection is “not recommend for or against ” . The OA Research Society International (OARSI) Guidelines  provide an “uncertain” recom- mendation for HA injection in the treatment of KOA, while do not mention the PRP injection. Meanwhile, Campbell  conducted a systematic review of overlap- ping meta-analyses, suggested that PRP injection may in- crease the local adverse reactions than HA. However, several meta-analyses [30–33, 35] published in the last 3 years indicated PRP injection does not have more ad- verse events than HA injection.