Research Protocol: Immediate weight bearing in a ...



Study TitleImmediate weight bearing in a functional orthotic brace for the conservative treatment of Achilles Tendon Rupture: A randomised controlled trialStudy InvestigatorsPrincipal Investigator (A): Mr Giles Foley1Ph. 043855999Email: Giles.Foley@.nzCo-Investigators (A):Dr Henry Smart2 & Dr Alice Rogan2Wellington Orthopaedic Department, Wellington Regional Hospital, Riddiford Street, Wellington, New ZealandWellington Emergency Department, Wellington Regional Hospital, Riddiford Street, Wellington, New ZealandAbstractAchilles tendon rupture is a common injury but to date there is no consensus with regards to the optimal conservative management strategy. For surgically managed Achilles tendon rupture guidelines support immediate weight bearing in functional orthotics due to the superior functional and clinical outcomes. We aim to compare the use of immediate weightbearing in functional orthotic braces versus standard non weight bearing management for conservatively managed Achilles tendon rupture. All patients presenting to Wellington Regional Hospital with Achilles tendon rupture will be screened for eligibility for the study. Included patients will be randomised to standard therapy in a non-weight bearing Equinus cast or a weight bearing VACOped orthotic brace. To obtain 80% power to detect a 10 point difference in Achilles Tendon Rupture Score (ATRS) at 6 months and allow for loss to follow up, this study will recruit 86 patients to each study arm. ATRS scores, VR-12 quality of life scores and complication rates will be collected at 3, 6, 9 and 12 months post injury. Results will be analysed on an intention to treat basis.BackgroundAchilles tendon rupture is a common injury and its prevalence is increasing as people remain active later into their lives1-5. The incidence has a bimodal distribution with peaks at ages 30-40 years and again at 60-80 years1. Typically rupture occurs in people with pre-existing tendinopathy6 during sports in the former age group and when climbing stairs in the latter1. Its rupture results in loss of plantarflexion necessary for walking, running and climbing stairs. Rupture is painful and has an immediate and significant impact on people’s lives2 that on average prevents them from working for 1-2 months and playing sport for 5-10 months1,7. Often patients never return to their pre-injury level of sports performance8.Healing is a slow process progressing through stages of early healing, remodelling and maturation that can take up to 12 months9. During this period there is a risk of re-rupture owing to the tendon having poor intrinsic tensile strength and therefore losing its ability to resist load10-12. There is debate with regards to how soon and by which method patients can load or weight bear on the tendon as it heals. Historically, ruptured Achilles tendons were managed surgically rather than conservatively due to evidence suggesting increased rates of re-rupture in conservatively managed patients13,14. However, large volumes of recent evidence have disproven this15. Furthermore, surgical repair predisposes patients to increased complications such as infection, skin necrosis and sural nerve damage9,15. Therefore, rates of conservative management are increasing and rates of operative repair are decreasing16. Originally standard practice was to place both surgically and conservatively managed patients into non-weight bearing gravity Equinus plaster casts for 6-8 weeks followed by targeted rehabilitation of the calf muscles. However, long term immobility can cause problems including muscle atrophy, musculoskeletal stiffness, DVTs and prolonged lower limb muscle weakness17-19. Theoretically, functional bracing and immediate protected weight bearing could prevent the problems associated with immobility as well as being more practical in terms of independent living and mobility3,20. Post-operative management in non-weight bearing plaster casts is reducing due to the increased use of treatment in weight bearing functional braces. Evidence strongly supports the latter in terms of improved functional outcomes, improved quality of life and comparative rates of re-rupture3, 19, 21-24. In surgically managed patients early weightbearing is associated with improved tendon healing and improved muscle regeneration3, 25-27. Consequently, the American Academy of Orthopaedic Surgeons recommends functional bracing for patients following surgical repair of the Achilles tendon28.However, to date no consensus has been established with regards to the optimal conservative management strategy28. A range of protocols and strategies have been used internationally including non-weight bearing casts and multiple weight bearing orthotic braces25, 29-31. There are also several variations in the length of time patients remain non-weight bearing followed by differing functional rehabilitation programmes32,33. To date only five RCTs3,30,31,34,35 have investigated early weight bearing in functional braces for the conservative treatment of Achilles tendon rupture and in fact only two30,31 have investigated immediate weight bearing. Encouragingly, so far results have shown no difference in rates of re-rupture, time to return to sports, time to return to work and calf strength. More evidence is required to determine the optimal management strategy for conservatively managed Achilles tendon rupture. Early evidence does suggest early mobilisation in functional orthotics could have clinical advantages in terms of faster rehabilitation and reduced detrimental effects of long term immobility.We aim to investigate the difference in clinical outcomes between patients with Achilles tendon rupture managed conservatively with immediate weight bearing in a functional orthotic brace compared with our hospitals current standard practice of six weeks non-weight bearing in an Equinus cast and moonboot. Our study hypothesises that conservative management of Achilles tendon rupture with immediate weight bearing in a functional orthotic will improve functional outcomes and quality of life as well as reducing complication rates compared with the more traditional approach of prolonged immobilisation. Aim of StudyThe aim of our study is to ascertain whether or not immediate weight bearing is superior to prolonged non-weight bearing in patients managed conservatively for Achilles tendon rupture in terms of functional outcomes and quality of life. ObjectivesThe primary objectives of the study is to examine the differences in Achilles Tendon Total Rupture Score (ATRS) between treatment groups 12 months following injury.The secondary objectives areTo examine the differences in ATRS scores at 3, 6 and 12 months post injury between treatment groups. To compare complication rates between treatment groups including re-rupture rates and DVT development.To evaluate for any disparity in Health-Related Quality of Life scores between the treatment groupsStudy Outcomes Primary OutcomeThe primary outcome measure for this study will be the Achilles Tendon Rupture Score (ATRS). It is a self-reported questionnaire, which has been validated and used in previous research investigating outcomes after Achilles tendon rupture36. This score will be collected at baseline, 3, 6, and 12 months after enrolment to the study. The ATRS consists of 10 questions that assess symptoms and physical activity specifically related to the Achilles tendon. It measures strength, fatigue, stiffness, pain, activities of daily living, walking on uneven surfaces, walking upstairs or uphill, running, jumping and physical labour. Individual items are converted to a 100-point scale with ‘0’ representing complete disability and 100 representing normal function. Secondary OutcomesHealth related quality of life scores will be collected using the Veterans RAND 12 Item Health Survey (VR-12?)37 at baseline, 3, 6 and 12 months post injury. The VR-12? is a brief, self-administered, validated quality of life survey. The items in the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The VR instruments use five-point ordinal response choices for four items in the VR-12?. Answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary plication data will be collected by directly asking patients if they have suffered any complications such as re-rupture or DVT and correlated with available medical records.At each of the time points patients will also be asked if they have returned to work, returned to sports and whether or not they are performing sports to same level as pre-injury and recorded on data collection forms. Methodology The study will be carried out in the Orthopaedic department at Wellington Regional Hospital, New Zealand. It will be single-centre study. This trial will be a prospective randomised controlled trial with two arms or treatment groups. The first group will include patients randomized to standard management in our department and the second group will include patients randomized into the intervention group involving the application of a VACOped boot (Oped Ag Ltd, Germany) and commencement of immediate weight bearing. It cannot be blinded as the treatment group will be clearly visible to the patient and treating team. Recruitment of participantsAll patients presenting to Wellington Hospital Orthopaedic Department with Achilles tendon rupture will be screened for eligibility for the trial. If a patient undergoes non-operative treatment and meets the criteria, then an appropriately trained member of the team will provide them with written and verbal information about the trial. Informed written consent to participate in the trial will be obtained if the patient decides to participate. Inclusion criteria Presenting within 72hrs of injuryIsolated unilateral injuryClosed injuryAged 16 or olderExclusion criteriaPresentation over 72hrs following injuryPrevious Ipsilateral Achilles tendon ruptureAssociated injuryRandomisation After informed written consent has been obtained, patients will be randomly allocated to the weight bearing or non-weight bearing groups on a 1:1 basis via the use of pre-prepared opaque envelopes. Study designAfter the randomisation process, the patient will have either the cast or the functional brace applied by a trained member of the orthopaedic clinic staff. This will be the 0 month time point. The standard treatment group will have a fiberglass cast applied in a gravity equinus position. They will be provided with crutches and advised to not-weight bear on the affected limb for 6 weeks. They will be reviewed in clinic at 2 weeks post randomisation for a clinical review, skin checks and change of cast. At 4 weeks post randomisation the fiberglass cast will be removed and the patient will be changed into a moonboot (SCL) with 3 heel wedges. They will be advised to remove the Moonboot 4 times a day perform non-weight-bearing range of motion exercises for 5 minutes. At 6 weeks post randomisation they will have one heel wedge removed and start to weight bear on the affected limb. At 8 weeks post randomisation patients will transition out of the moonboot into normal shoes with 1.5cm orthotic heel raises. At this stage they will commence standardised physiotherapy. The heel raises will be removed at 12 weeks post randomisation. The intervention group will have a VACOped? boot applied at randomisation and follow a previously published protocol24. This boot can be locked at fixed degrees of equinus and also allow limited dynamic movement in a range of equinus degrees. Patients will be able to fully weight bear on the affected limb in this boot. It will be locked at 30 for 4 weeks. The patients will return to clinic at 2 weeks post randomisation for a clinical review. The boot will be removed and skin checked. The liner will be changed and the boot reapplied. At 4 weeks post randomisation the patients will return to clinic for a clinical review and skin checks. The liner will be changed and the boot reapplied with 15-30 dynamic movement. At 6 weeks post randomisation the patients will return to clinic for a clinical review and skin checks. The liner will be changed and the boot reapplied with 0-30 dynamic movement. At 8 weeks post randomisation the VACOped? boot will be removed and the patients will commence standardised physiotherapy in their own normal shoes. The study participants will be asked to complete the ATRS and HRQOL questionnaires when they are randomized. The same questionnaires will be completed again at 3, 6 and 12 months post injury. The questionnaires at these timepoints will be completed via telephone for patient convenience. For the first 8 weeks, any adverse events will be collected during clinic reviews, be these routine clinic appointments or unscheduled appointments. After this period patients will be asked about any adverse events or complications during the aforementioned telephone calls. Patients will also have the telephone number for the clinic to contact the team at any point to inform us about any complications or adverse events as well as to discuss any other questions they may have about their treatment. The trial will end when the last enrolled patient completes the be at the collection of the 12 months ATRS and complication questionnaire. Statistical Considerations and Data AnalysisSample size and statistical powerAs stated above the primary outcome measure for this study is the ATRS. The minimum clinically significant difference we have chosen for the ATRS for this study is 10. The original ATRS validation study determined a standard deviation of 21.44. With an alpha power of 0.05 and a power of 80% the minimum sample size has been calculated as 72 per treatment arm. To ensure the results are not affected by patients lost to follow up a 20% margin above this number has been selected. Therefore, the aim will be to have 86 patients randomized to each treatment arm in order to provide sufficient power to detect the minimum clinically significant difference.Statistical methods and Data CollectionRaw data will be collected on pre-printed data proforma and questionnaire forms. At baseline patient’s demographic and injury details will be collected as well as baseline ATRS and VR-12? questionnaires. This data will be entered into a secure password protected database such as Microsoft Excel. Baseline characteristics will be summarized and compared between the two groups. Analysis of primary outcome measures will be completed on an intention-to-treat basis. The main results reported will include differences in ATRS and HRQOL scores at 3, 6, and 12 months. Complications rates will be recorded and compared at 12 months. Comparison of time away from work and sport will be compared at 12 months. Statistical analysis will be completed using a validated statistical programme such as SPSS. Mean ATRS and HRQOL scores will be compared using two sided student t-tests at the various time points. Linear mixed effect regression analysis of ATRS and HRQOL scores will also be completed and adjusted for confounding factors such as gender and age. Results will be deemed significant if p values are smaller than 0.05. Data will also be collected with regards to the number of ineligible patients, patient withdrawal and loss to follow up. Missing data will be accounted for and reviewed prior to a final statistical plan being implemented. Interim data analysis will occur at the 3 and 6 month mark to assess whether or not changes in data collection or statistical analysis will be required. Interim data monitoringEthical Considerations The study will be conducted in full conformance with principles of the “Declaration of Helsinki”, Good Clinical Practice (GCP) of the Medical Council of New Zealand, the Health and Disability Ethics Committee, the District Health Board research board, and within the laws and regulations of New Zealand.Data collected will be stored anonymously and stored securely in accordance with local DHB guidelines.Participants will be able to withdraw from the study at any point. The decision will not affect the standard of care the patient receives. If a participant wishes to withdraw they will be given to option of withdrawing completely from the study or allowing the trial team to continue to anonymously collect any relevant hospital data that is recorded as part of their standard care. 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