Amputation Neuroma
Conditions
Keywords
Amputation, Regenerative peripheral nerve interface, Neuroma
Brief summary
The trial will be carried out in Peking University People's Hospital. The whole trial will last 3 years. Amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(RPNI) surgery.The pain outcome,the impact of post-amputation pain on life and the utilization rate of prostheses will be collected to study the efficacy, safety and prognosis of preventive regenerative peripheral nerve interface reconstruction in amputees. Investigators believe that RPNI can effectively reduce the incidence of post-amputation pain, reduce the degree of pain, improve the wearing rate of prostheses, and help patients return to normal life.
Interventions
PROCEDUREpreventive regenerative peripheral nerve interface reconstruction
Each RPNI unit consists of nerve stump and free autologous muscle graft that is cut off from healthy muscle of the amputated limb. The muscle graft is approximately 30×15×5 mm.The ends of the transected nerve are placed within the muscle belly of the free muscle grafts in an orientation that is parallel to the muscle fibers. Next, the nerve is secured distally with 6-0 non-absorbable monofilament sutures in an epimysial-to-epineurial fashion. The nerve is then wrapped around completely via muscle graft and epimysial securing sutures. All RPNI units are placed in areas remote from the surgical incision and from the weight-bearing surface of the limb.
Sponsors
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The investigator who perform the operations cannot be blinded because of the use of manual techniques.
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital * Age≥6 years * Follow-up time≥12 weeks
Exclusion criteria
* Follow-up time\<12 weeks * Age\<6 years * Preoperative complications included cervical spondylosis, lumbar spinal stenosis, piriformis syndrome, cubital tunnel syndrome and other peripheral nerve entrapment syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postamputation pain | 12 weeks at least after surgery | Patient-Reported Outcomes Measurement Information System (NRS, PROMIS) were used to assess postamputation pain.The intensity of pain is described by 11 points from 0 (painless) to 10 (the most severe pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis wearing | 12 weeks at least after surgery | Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn. |
| Tumor recurrence and metastasis | 12 weeks at least after surgery | Whether there is tumor recurrence or metastasis. |
| Quality of life | 12 weeks at least after surgery | The medical outcomes study-short from(MOS-SF 36) is used to evaluate the difference between the RPNIs group and the control group in the quality of life after amputation.The SF-36 scale consists of 36 questions with eight dimensions:physiological function, role-physiological, physical pain, general health, vitality, social function, role-emotional, and mental health. The scoring method was used for each dimension, ranging from 0 to 100 points. The higher the score, the better the health status. |
Countries
China
Contacts
Primary ContactGuangxue Li
Outcome results
None listed