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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.

ABSTRACT: INTRODUCTION:The 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 ANALYSIS:PHACT 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 DISSEMINATION:Ethical 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 NUMBER:NCT03311997.

SUBMITTER: Pihl E

PROVIDER: S-EPMC6747659 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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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.

Pihl Elsa E Kristoffersen Målfrid Holen MH Rosenlund Anne-Mari AM Laszlo Sofia S Berglöf Mida M Ribom Eva E Eriksson Karl K Frihagen Frede F Mattila Ville M VM Schilcher Jörg J Eklund Martin M Snellman Greta G Skorpil Mikael M Sköldenberg Olof O Hedbeck Carl Johan CJ Jonsson Kenneth K

BMJ open 20190913 9

<h4>Introduction</h4>The 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.<h4>Methods and analysis</ ...[more]

PMID: 31519683

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Project description:Ischial avulsion fractures classically occur in the pediatric population and are relatively uncommon. These injuries are treated conservatively; however, in cases where there is greater than 2 cm of displacement, surgical intervention is recommended. In some cases, displaced fractures are either misdiagnosed or proper treatment is neglected, and patients who transition into adulthood are left with chronic nonunions that can become a source of pain and disability. Here we present a surgical technique for a chronic ischial avulsion fracture nonunion that is excised, and the hamstring tendons are then primarily repaired to the ischium using suture anchors. Technique Video Video 1 This is a video for the surgical intervention for a patient with a chronic right sided ischial avulsion fracture. The patient is placed in the prone position with all bony prominences padded. After a standard sterile prep and drape of the right lower extremity, an 8 to 10 cm incision is made in the gluteal crease, overlying the right-sided ischium. Electrocautery is used to reveal the underlying gluteal fascia. The gluteal fascia is incised using dissecting scissors. A Schnitt is used to open the interval inferior to the gluteus maximus muscle, and a large retractor is placed. A sciatic neurolysis is performed. The chronic avulsion fracture is revealed using electrocautery. A combination of electrocautery and a cobb elevator is used to free the bony fragment. After removal, the eburnated surface of the ischium is revealed. A combination of curettes and osteotomes are used to create a bleeding bone bed on the native ischium. Next, two 2.8 mm Q-fix (Smith and Nephew, Andover, MA) double-loaded all-suture anchors are placed into the native ischium. From each anchor, 1 suture limb from 1 pair is passed through the hamstring tendon in a locking fashion while the other is left free. From the other suture pair from the same anchor, one limb is passed in a modified Mason-Allen technique, and the other limb is left free. This is repeated for the other anchor. Using the free limbs of the anchors, the tendon is delivered to the ischium. The corresponding suture limbs are tied, and the free ends are cut with a knife. After copious irrigation a multilayer closure is performed. Dermabond is placed on the skin and a dry sterile dressing. After surgery the patient is made flat foot weightbearing in a hip orthosis and is started on chemical anticoagulation. At the first postoperative visit the wound is evaluated, and an X-ray film is obtained. (Soundtrack: Morning Routine by Ghostrifter Official | https://soundcloud.com/ghostrifter-official Music promoted by https://www.chosic.com/free-music/all/Creative Commons CC BY-SA 3.0 https://creativecommons.org/licenses/by-sa/3.0/)

Project description:BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.MethodsMulticentre, international, randomised controlled trial with a non-inferiority design. Children (age 5-16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.DiscussionThe APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.Trial registration numberclinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.

Project description:PurposeProximal hamstring tendinopathy (PHT) presents as localised lower buttock pain with tasks such as squatting and sitting. It is a condition that occurs at all ages and levels of sporting participation and can cause disability with sport, work, and activities of daily living. This paper details a pilot trial protocol for investigating the effectiveness of individualised physiotherapy compared to extracorporeal shockwave therapy (ESWT) on pain and strength in people with PHT.MethodsThe study is an assessor-blinded, pilot randomised controlled trial (RCT). One hundred participants with PHT will be recruited from the local community and sporting clubs. Participants will be randomised to receive six sessions of either individualised physiotherapy or ESWT, with both groups also receiving standardised education and advice. Primary outcomes will be global rating of change on a 7-point Likert scale, and the Victorian Institute of Sport-Hamstring (VISA-H) scale, measured at 0, 4, 12, 26 and 52 weeks. Secondary outcomes will include sitting tolerance, the modified Physical Activity Level Scale, eccentric hamstring strength, modified Tampa scale for kinesiophobia, the Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF), Numerical Pain Rating Scale (NPRS) for average and worst pain, participant adherence, the Pain Catastrophizing scale, satisfaction scores, and quality of life. Data will be analysed on an intention to treat basis, with between-group effects estimated using linear mixed models for continuous data and Mann Whitney U tests for ordinal data.ConclusionsThis pilot RCT will compare individualised physiotherapy versus ESWT for PHT. The trial will determine feasibility and estimated treatment effects to inform a definitive trial in the future.Trial registrationThe trial has been prospectively registered with the Australia & New Zealand Clinical Trials Registry (ACTRN12621000846820), registered 1 July 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373085.

Project description:BackgroundAlthough increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.Methods and findingsThe NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.ConclusionsThis trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.Trial registrationClinicalTrials.gov NCT01246167.

Dataset Information

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.

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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.

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