The osteoarthritis thumb therapy (otter) ii trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost- effectiveness of splints for symptomatic thumb base osteoarthritis

HIGHLIGHTS

• who: The Osteoarthritis Thumb Therapy and collaborators from the adverse events must be assessed for causality and reason for seriousnessAll device deficiencies, adverse reactions and adverse device effects must be reported to the trial team within , days. All serious adverse event safety monitoring forms will be passed on to the Trial`s Nominated Clinician who will perform an independent assessment of causality and will also perform assessment of expectedness based on what is known and documented about the intervention/device. Any SUSARs will be reported to the Research Ethics Committee within , days of the Trials Office being . . .
  

   

  

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