Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator
The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
A 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture will be used to repair Zone 2 FDP tendon laceration(s).
Grootte Schuur Hospital
Cape Town, South Africa
Tygerberg Hospital
Cape Town, South Africa
Inkosi Albert Luthuli Central Hosptial
Durban, South Africa
Chris Hani Baragwanath Academic Hosptial
Soweto, South Africa
Rate of tendon re-rupture
Primary Safety Endpoint
Time frame: 24 weeks
Mobility of the affected digits using Strickland's Revised Score
Primary Effectiveness Endpoint-Strickland's Revised Score provides a descriptive measure of the mobility of digits. Range of motion measurements taken on the studied digits are used to generate a score on a 0 (least mobile) to 100 (most mobile) with outcomes being classified as: excellent (75-100%), good (50-784%), fair (25-49%), or poor (\<25%).
Time frame: 24 weeks
Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 24 weeks
Surgical Site Infection
Presence of infection at the surgical site
Time frame: 24 weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire
DASH is a patient-reported questionnaire consisting of 30 questions designed to evaluate a patients ability to perform certain upper extremity activities. The patients answers are used to calculate a score from 1 (most disabled) to 100 (least disabled). DASH is validated to be able to detect small and large changes over time, most notably before and after surgical interventions in the upper extremity.
Time frame: 24 weeks
Grip Strength measured using a dynamometer with values for the affected hand being calculated as a percentage of the grip strength of the unaffected hand
The average of three grip strength values taken in succession (kilograms).
Time frame: 24 weeks
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Tip pinch strength measured with a pinch gauge with values for the affected fingers calculated as a percentage of the tip pinch strength for corresponding fingers on the unaffected hand
The average of three tip pinch strength values taken in succession (kilograms).
Time frame: 24 weeks