Clinical Trials in Orthopedic Disorders

Polyetheretherketone cages used in anterior cervical discectomy and fusion surgery: a meta-analysis Sukrit Sharma, Shakti Amar Goel, Sunil Sharma, Harvinder Singh Chhabra Clinical Trials in Orthopedic Disorders 2019 4(2):29-33 Background and objective: In the current clinical scenario, a wide variety of fusion techniques are being used along with polyetheretherketone (PEEK) cages in anterior cervical discectomy and fusion surgeries. Some of these techniques involve use of autografts, allografts, biomaterials or only PEEK cages. In this study, the existing literatures for anterior cervical discectomy fusion surgeries using PEEK cages and their outcomes have been reviewed to evaluate the results for the best possible alternative. Materials and methods: A PubMed search for all papers stating “PEEK cages used in cervical spinal fusion,” “PEEK materials used in cervical spinal fusion,” and “artificial materials used in cervical fusion surgery with PEEK cages” was done for all studies before January 2018. A total of 197 studies were found, of which 15 were shortlisted as per the inclusion criteria. The existing literatures on PEEK cages used in spinal surgeries were reviewed and analyzed. Statistical analysis was done using SPSS software version 25.0 and Student’s t-test was used to compare the results. Results: The total number of patients involved in the existing study was 767 with a mean age of 51.67 ± 9.01 years. 191 patients (24.9%) had cervical radiculopathy or myelopathy; 35 patients (4.5%) had cervical degenerative diseases; 29 patients (3.78%) had cervical spine injury with monosegmental instability; and the rest of the patients suffered from other disorders. The level of surgery for patients was single in 429 patients (55.93%) and multiple in 338 patients (44.06%). PEEK plus bone grafts had a significantly better fusion rate compared with PEEK plus artificial materials (95% confidence interval: 91.075 ± 2.09%; P = 0.0035) for multiple-level anterior cervical discectomy and fusion surgery. Conclusion: PEEK plus bone grafts showed a significant fusion rate compared with PEEK plus artificial materials. PEEK plus bone grafts is a better filler material as compared to PEEK plus artificial materials in anterior cervical discectomy and fusion surgeries for multiple levels involved.

Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial Xiao-Guang Yang, Ying-Zhen Wang Clinical Trials in Orthopedic Disorders 2019 4(2):34-40 Background and objective: Anterior cruciate ligament tibial eminence avulsion fractures are repaired via early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification. The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture. Participants and methods: This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is 1.0. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves. Results: The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and magnetic resonance images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (P < 0.05). Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores were significantly improved 6 months postoperatively compared with preoperatively (P < 0.05). Conclusion: This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture. Trial registration: This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865).

Alexandros Sfakianakis
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