scholarly journals The proximal hamstring avulsion clinical trial (PHACT)—a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e031607 ◽  
Author(s):  
Elsa Pihl ◽  
Målfrid Holen Kristoffersen ◽  
Anne-Mari Rosenlund ◽  
Sofia Laszlo ◽  
Mida Berglöf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Operative Treatment ◽  
Controlled Trial ◽  
Prospective Trial ◽  
Functional Score ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Proximal Hamstring Avulsion ◽  
Proximal Hamstring

IntroductionThe treatment of proximal hamstring avulsions is controversial. While several trials have investigated the outcome for patients treated surgically, there is today no prospective trial comparing operative treatment with non-operative treatment. This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)—the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions.Methods and analysisPHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment. Participants allocated to surgery will undergo reinsertion of the tendons with suture anchors. The rehabilitation programme will be the same for both treatment groups. When patient or surgeon equipoise for treatment alternatives cannot be reached and randomisation therefore is not possible, patients will be invited to participate in a parallel observational non-randomised cohort. The primary outcome will be the patient-reported outcome measure Perth hamstring assessment tool at 24 months. Secondary outcomes include the Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging. Data analysis will be blinded and intention-to-treat analysis will be preformed.Ethics and disseminationEthical approval has been granted by the Ethical Committee of Uppsala University (DNR: 2017–170) and by the Norwegian ethical board (REC: 2017/1911). The study will be conducted in agreement with the Helsinki declaration. The findings will be disseminated in peer-reviewed publications.Trial registration numberNCT03311997

Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Resource Assessment ◽  
Trial Registration ◽  
Residential Aged Care ◽  
Cluster Randomised ◽  
Intervention Adherence ◽  
Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

scholarly journals Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol—non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024916 ◽  
Author(s):  
Antti P Launonen ◽  
Tore Fjalestad ◽  
Minna K Laitinen ◽  
Tuomas Lähdeoja ◽  
Carl Ekholm ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Operative Treatment ◽  
Shoulder Arthroplasty ◽  
Large Scale ◽  
Proximal Humerus Fracture ◽  
Proximal Humerus ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Humerus Fracture ◽  
Randomised Controlled

IntroductionThe proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%–33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment.MethodsThis is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65–85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH.Ethics and disseminationIn this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication.Trial registration numberNCT03531463; Pre-Results.

scholarly journals The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029054 ◽  
Author(s):  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Systemic Disease ◽  
Chest Ct ◽  
Tumor Surgery ◽  
Free Survival ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionFollowing the treatment of patients with soft tissue sarcomas (STS) that are not metastatic at presentation, the high risk for local and systemic disease recurrence necessitates post-treatment surveillance. Systemic recurrence is most often detected in the lungs. The most appropriate surveillance frequency and modality remain unknown and, as such, clinical practice is highly varied. We plan to assess the feasibility of conducting a multi-centre randomised controlled trial (RCT) that will evaluate the effect on overall 5-year survival of two different surveillance frequencies and imaging modalities in patients with STS who undergo surgical excision with curative intent.Methods and analysisThe Surveillance After Extremity Tumor Surgery trial will be a multi-centre 2×2 factorial RCT. Patients with non-metastatic primary Grade II or III STS treated with excision will be allocated to one of four treatment arms1: chest radiograph (CXR) every 3 months for 2 years2; CXR every 6 months for 2 years3; chest CT every 3 months for 2 years or4 chest CT every 6 months for 2 years. The primary outcome of the pilot study is the feasibility of a definitive RCT based on a combination of feasibility endpoints. Secondary outcomes for the pilot study include the primary outcome of the definitive trial (overall survival), patient-reported outcomes on anxiety, satisfaction and quality of life, local recurrence-free survival, metastasis-free survival, treatment-related complications and net healthcare costs related to surveillance.Ethics and disseminationThis trial received provisional ethics approval from the McMaster/Hamilton Health Sciences Research Ethics Board on 7 August 2019 (Project number 7562). Final ethics approval will be obtained prior to commencing patient recruitment. Once feasibility has been established and the definitive protocol is finalised, the study will transition to the definitive study.Trial registrationNCT03944798; Pre-results.

scholarly journals Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032901 ◽  
Author(s):  
Christelle Pons ◽  
Dauphou Eddi ◽  
Gregoire Le Gal ◽  
Marc Garetier ◽  
Douraied Ben Salem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Randomised Controlled Trial ◽  
Humeral Head ◽  
Controlled Trial ◽  
Birth Injury ◽  
Posterior Subluxation ◽  
Randomised Controlled ◽  
Botulinum Toxin Injections ◽  
Brachial Plexus Birth Injury

IntroductionIn children with brachial plexus birth injury (BPBI), denervation of the shoulder muscles leads to bony deformity in the first months of life, reducing active and passive range of motion (ROM) and causing activity limitation. The aim of this multicentre randomised controlled trial is to evaluate the effectiveness of botulinum toxin injections (BTI) in the shoulder internal rotator muscles of 12-month-old babies in limiting the progression of posterior subluxation of the glenohumeral joint, compared with a sham procedure mimicking BTI. The secondary aims are to evaluate the effectiveness of BTI in (1) limiting the progression of glenoid retroversion and three-dimensional (3D) deformity and (2) improving shoulder ROM and upper limb function, as well as to confirm the tolerance of BTI.Methods and analysisSixty-two babies with unilateral BPBI and a risk of posterior humeral head subluxation will be included. Only those with at least 7% posterior subluxation of the humeral head compared with the contralateral shoulder on the MRI will be randomised to one of two groups: ‘BTI’ and ‘Sham’. The BTI group will receive BOTOX injections at the age of 12 months in the internal shoulder rotator muscles (8 UI/kg). The sham group will undergo a sham BTI procedure. Both groups will undergo repeated shoulder MRI at 18 months of age to quantify changes in the percentage of posterior migration of the humeral head (primary outcome), glenoid version and 3D bone deformity. Clinical evaluations (passive shoulder ROM, active movement scale) will be carried out at baseline and 15 and 18 months of age. The mini-assisting hand assessment will be rated between 10 and 11 months and at 18 months of age. Adverse events will be recorded at least monthly for each child.Ethics and disseminationFull ethical approval for this study has been obtained. The findings will be disseminated in peer-reviewed publications.Trial registration numberEudraCT: 2015-001402-34 in European Clinical Trial database;NCT03198702in Clinical Trial database; Pre-results.

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