Ankle Fractures Clinical Trial
— PASSOfficial title:
Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial
Verified date | March 2023 |
Source | Kuwait Institute for Medical Specialization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Ankle fractures are some of the most common orthopedic presentations, however, controversy in their management and their post-operative rehabilitation protocols exist. Most displaced ankle fractures treated with anatomical reduction and stable internal fixation to allow early range of motion by allowing rigid fixation and restoration of ankle joint congruence. Post-operative rehabilitation protocols varies between surgeons and institutions with the majority emphasising early rehabilitation protocols. The use of a splint. The rational for splinting ankle fractures after rigid fixation is to decrease pain level, rest the soft tissues and prevent equinus deformity. Up to date there is no scientific research to question the benefit of routine use of splints after rigid fixation of ankle fractures. Methods: A prospective multi-centre randomised control trial. Approximately fifty patients will be enrolled from 3 hospitals (Adan, Mubarak and Farwaniya hospital) over a 1 year period. The studied sample will be randomised into 2 groups using computerised randomisation software: splint group and no-splint group. The patients will be examined at set intervals for pain, swelling, deep-vein thrombosis and a set of scoring tools. The tools include: visual analogue score (VAS) for pain, Short Form Health Survey (SF-36), American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score, physical and radiological assessment at 2 weeks, 3 months, 6 months and 1 year intervals. Statistical Package for the Social Sciences program (SPSS) will be used for statistical analysis Results/outcomes: Functional scores, symptoms and signs, complications, radio-graphic and clinical follow up will be recorded.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - A.O 44 ankle fractures requiring surgical fixation (uni or bimalleolar with /without syndesmotic injury) Exclusion Criteria: - pathological fracture - poly trauma pilon fractures open fractures other associated fractures in same extremity peripheral neuropathy |
Country | Name | City | State |
---|---|---|---|
Kuwait | Mubarak Al kabeer hospital | Kuwait |
Lead Sponsor | Collaborator |
---|---|
Kuwait Institute for Medical Specialization | Kuwait University |
Kuwait,
Ahl T, Dalen N, Selvik G. Mobilization after operation of ankle fractures. Good results of early motion and weight bearing. Acta Orthop Scand. 1988 Jun;59(3):302-6. doi: 10.3109/17453678809149368. — View Citation
Daly PJ, Fitzgerald RH Jr, Melton LJ, Ilstrup DM. Epidemiology of ankle fractures in Rochester, Minnesota. Acta Orthop Scand. 1987 Oct;58(5):539-44. doi: 10.3109/17453678709146395. — View Citation
Honkanen R, Tuppurainen M, Kroger H, Alhava E, Saarikoski S. Relationships between risk factors and fractures differ by type of fracture: a population-based study of 12,192 perimenopausal women. Osteoporos Int. 1998;8(1):25-31. doi: 10.1007/s001980050044. — View Citation
Lin CW, Donkers NA, Refshauge KM, Beckenkamp PR, Khera K, Moseley AM. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2012 Nov 14;11:CD005595. doi: 10.1002/14651858.CD005595.pub3. — View Citation
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Smeeing DP, Houwert RM, Briet JP, Kelder JC, Segers MJ, Verleisdonk EJ, Leenen LP, Hietbrink F. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015 Feb 19;10(2):e0118320. doi: 10.1371/journal.pone.0118320. eCollection 2015. — View Citation
Valtola A, Honkanen R, Kroger H, Tuppurainen M, Saarikoski S, Alhava E. Lifestyle and other factors predict ankle fractures in perimenopausal women: a population-based prospective cohort study. Bone. 2002 Jan;30(1):238-42. doi: 10.1016/s8756-3282(01)00649-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing the change in the level of pain between the splint and no-splint groups | Visual analogue scale (0;lowest pain, 10;highest pain) | Change in pain from 2 weeks postop to 1 year postop | |
Primary | Assessing the change in ankle swelling from 2 weeks postop to 1 year postop in the splint and no-splint groups | Measuring tape to assess supramalleolar, mid-foot, and mid-calf circumference | Change in swelling from 2 weeks postop to 1 year postop | |
Secondary | Change in the functional scoring system used below | The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score | Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scorefrom 2 weeks postop to 1 year postop | |
Secondary | Number of participants with; infection, nonunion, deep-vein thrombosis, stiffness, equinus | Rate of infection, nonunion, deep-vein thrombosis, stiffness, equinus | From 2 weeks postop - 1 year postop |
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