ABSTRACT
A new nerve matrix membrane derived from decellularized porcine nerves has been shown to retain the major extracellular matrix components, and to be effective in preventing adhesion between the nerve anastomosis sites and the surrounding tissues in a rat sciatic nerve transection model, thereby enhancing regeneration of the nerve. The effectiveness of the membrane may be attributed to its various bioactive components. In this prospective, randomized, single-blind, parallel-controlled multicenter clinical trial, we compared the safety and efficacy of the new nerve matrix membrane with a previously approved bovine tendon-derived type I collagen nerve wrapping. A total of 120 patients with peripheral nerve injury were recruited from Beijing Jishuitan Hospital, The First Bethune Hospital of Jilin University, and Yantai Yuhuangding Hospital, China. The patients were randomly assigned to undergo end-to-end and tension-free neurorrhaphy with nerve matrix membrane (n = 60, 52 male, 8 female, mean age 41.34 years, experimental group) or tendon-derived collagen nerve wrapping (n = 60, 42 male, 18 female, mean age 40.17 years, control group). Patients were followed-up at 14 ± 5, 30 ± 7, 90 ± 10 and 180 ± 20 days after the operation. Safety evaluation included analyses of local and systemic reactions, related laboratory tests, and adverse reactions. Efficacy evaluation included a static 2-point discrimination test, a moving 2-point discrimination test, and a Semmes-Weinstein monofilament examination. Sensory nerve function was evaluated with the British Medical Research Council Scale and Semmes-Weinstein monofilament examination. The ratio (percentage) of patients with excellent to good results in sensory nerve recovery 180 ± 20 days after the treatment was used as the primary effectiveness index. The percentages of patients with excellent to good results in the experimental and control groups were 98.00% and 94.44%, respectively, with no significant difference between the two groups. There were no significant differences in the results of routine blood tests, liver and renal function tests, coagulation function tests, or immunoglobulin tests at 14 and 180 days postoperatively between the two groups. These findings suggest that the novel nerve matrix membrane is similar in efficacy to the commercially-available bovine-derived collagen membrane in the repair of peripheral nerve injury, and it may therefore serve as an alternative in the clinical setting. The clinical trial was approved by the Institutional Ethics Committee of Beijing Jishuitan Hospital, China (approval No. 20160902) on October 8, 2016, the Institutional Ethics Committee of the First Bethune Hospital of Jilin University, China (approval No. 160518-088) on December 14, 2016, and the Institutional Ethics Committee of Yantai Yuhuangding Hospital, China (approval No. 2016-10-01) on December 9, 2016. The clinical trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR2000033324) on May 28, 2020.
ABSTRACT
PROPOSE: To analyze the clinical and epidemiological features of patients who underwent wrist arthroscopy procedures. METHODS: This is a cross-sectional epidemiological study. The study included a cohort of patients who underwent wrist arthroscopy procedures in a national orthopaedic referral center from 1 February, 2014 to 1 February, 2019. The medical records, diagnosis, and every wrist arthroscopy procedure of all the patients were collected and reviewed. The epidemiological features, detail of the diagnoses, and the procedures of all the patients were systemically analyzed. All the patients were divided into two groups: trauma and non-trauma conditions. The complexity of the wrist arthroscopy procedure was classified into simple procedures (exploration or debridement) and complex procedures (repair or reconstruction). χ2 test was used to compare proportions between the procedures of different complexity and the two groups of patients. RESULTS: A total of 533 patients (332 males and 201 females) were included in this study. More than half (56%) of the patients were in the age group 21-40 and nearly two thirds (62%) of all the 533 patients were male. The diagnoses of all the patients could be classified into eight categories: (i) TFCC injury; (ii) ulnar impactions syndrome; (iii) carpal trauma (carpal bone fractures and/or carpal ligament injures); (iv) distal radius fractures; (v) carpal bone cyst or necrosis; (vi) ganglion cyst; (vii) wrist arthritis; and (viii) disorders of small joint of the hand. The most common conditions treated with wrist arthroscopy were TFCC injury (172 cases), followed by carpal trauma (125 cases) and ulnar impaction syndrome (84 cases). The simple arthroscopic procedures (exploration or debridement) account for 53% of all the procedures while complex reparative or reconstructive procedures account for 47%. There was a significant difference in the proportion between simple procedures and complex procedures in both trauma and non-traumatic patients. Repair or reconstruction procedures were more frequently performed for wrist trauma patients, whereas exploration or debridement procedures were more frequently performed for non-trauma patients. CONCLUSIONS: The largest group of patients who underwent wrist arthroscopy surgery are those who complained of ulnar-sided wrist pain and the commonly conducted wrist arthroscopy procedures have evolved from simple exploration/debridement to the more complex repair or reconstruction procedures in China.