Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial

Table 1 Study outcome measures

Item	Outcome measurement [unit]	Time point of measurement	Primary/secondary outcome parameter?
Tactile gnosis**	Static 2-point-discrimination [mm]	at 6 months postoperatively**	primary**
Tactile gnosis**	Static 2-point-discrimination [mm]	at 3, 12, and 24 months postoperatively**	secondary**
Sensory re-innervation	Semmes Weinstein method [grading]	at 3, 6, 12, and 24 months postoperatively	secondary
Disabilities in activities of daily living	DASH questionnaire [score]	at 3, 6, 12, and 24 months postoperatively	secondary
Grip strength	Jamar dynamometer [kg; percentage of contralateral side]	at 3, 6, 12, and 24 months postoperatively	secondary
Motion	Total active range of motion [degree]	at 3, 6, 12, and 24 months postoperatively	secondary
Pain, cold intolerance, hypersensitivity	Visual analog scales [points out of ten]	at 3, 6, 12, and 24 months postoperatively	secondary
Appearance of neuroma	Clinical examination and sonography [count]	at 3, 6, 12, and 24 months postoperatively	secondary

** Tactile gnosis measured by static two-point-discrimination 6 months postoperatively will be considered as the primary outcome parameter. Tactile gnosis** measured by the static two-point discrimination at 3, 12, and 24 months postoperatively will be considered as the secondary outcome parameters

ISSN: 1745-6215