A clinical trial for the assessment of effect of oral ibuprofen drug on the outcome post repair of hand flexor tendons

Title: A double blind randomised controlled trial assessing the effect of oral ibuprofen on outcome of flexor tendon repairs Short Title: Ibuprofen Flexor Tendon Trial (IFTT) Design: Double Blind Randomised Controlled Trial Hospital/s: Gold Coast Hospital and Health Service Study Question: Does oral ibuprofen influence outcome in patients post flexor tendon repair? Primary purpose of the study: This study has been designed to assess the effect of using oral ibuprofen after repair of hand flexor tendons on function and final outcome of hand . Study hypothesis is that use of oral ibuprofen after flexor tendon repair will result in improved outcome in comparison to when ibuprofen is not given.Ibuprofen should also result in decreased swelling of fingers. Many work hours will be saved and quality of life will be improved in flexor tendon repair patients if the study hypothesis is found to be true and a cheap and easily available drug like ibuprofen can reduce financial burden of these injuries on society and community. Study Objectives: Primary Objectives: Assessment of the effect of oral ibuprofen on outcome of flexor tendon repairs in humans: 1) Range of motion assessment using Strickland criteria 2) Range of motion assessment using ASSH criteria 3) Grip strength assessment 4) Michigan Hand Outcomes Questionnaire for evaluation of hand outcome Secondary Objectives: 1) Assessment of finger circumference 2)Assessment for delayed wound healing 3) Assessment for rupture of tendons 4) Assessment of need for tenolysis or follow up surgeries. Inclusion Criteria: 18 years of age and above Exclusion Criteria: Contraindication to NSAIDs/ibuprofen, systemic conditions/diseases like cardiac, renal, CNS, GI and others, documented allergy to NSAIDs Number of Planned Subjects: 66 Investigational product: Oral Ibuprofen Safety considerations: Coexisting cardiovascular, gastrointestinal and renal diseases; certain drugs Statistical Methods: Two arm trial- interventional and control. Two-sample t-test for a type 1 error (alpha) of 0.05 and a power of 90% for sample size calculation.