Upper Limb Peripheral Nerve Injury
Conditions
Interventions
Experimental group:Use Absorbable Peripheral Nerve Repair Materials
Control Group:Use Acellular Matrix Peripheral Nerve Repair Membrane
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)age >=18 years and < 70 years; 2)Upper limb traumatic nerve injury (with an injury gap that can be end-to-end anastomosed) or cubital tunnel syndrome; 3)Signed informed consent form; 4)The injured site is operable; 5)There is an uninjured contralateral upper limb or adjacent finger, suitable as a reference for baseline function assessment; 6)able to comply with all aspects of the treatment and evaluation plan within a 12-month period; 7)no pregnant or breastfeeding; 8)No autoimmune diseases or other serious physical illnesses that may affect the study; 9)No mental disorders; 10)No history of neuropathy, diabetic neuropathy, or other known neuropathies; 11)No history of chronic ischemic disease or vasculitis in the upper limbs.
Exclusion criteria
Exclusion criteria: 1)Participation in other clinical studies within the past 3 months; 2)unable to do surgery; 3)Allergy to the repair materials; 4)Extensive soft tissue injury that affects the assessment of recovery; 5)Known medications that will be used during the study period and are known to affect nerve regeneration or cause peripheral neuropathy; 6)Subjects who are currently receiving or are expected to receive chemotherapy, radiation therapy, or other treatments known to affect the growth of the nervous and/or vascular system; 7)Multiple segment injuries of a single nerve; 8)Injuries distal to the distal interphalangeal joint; 9)Side-to-end nerve repair; 10)Injuries where vascular damage leads to insufficient perfusion after nerve repair; 11)Other forms of interfering injuries at the nerve ends, such as crush or traction injuries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meaningful Sensory Recovery Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The British Medical Research Council Sensory Function Scale;Visual Analogue Scale;Semmes-Weinstein Monofilament;superficial sensation;Static Two-Point Discrimination / Dynamic Two-Point Discrimination;The British Medical Research Council Motor Function Scale;Grip Strength;Finger Joint Range of Motion;Pinch Force;Upper Extremity Function Assessment; | — |
Countries
China
Contacts
Public ContactLi Wencui
Shenzhen Second People's Hospital
Outcome results
None listed