Clinical Trials in Orthopedic Disorders

RESEARCH ARTICLE
Year
: 2019  |  Volume : 4  |  Issue : 2  |  Page : 34--40

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 Yang1, Ying-Zhen Wang2 
1 Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan, Gansu Province, China
2 Department of Orthopedics, Second Clinical Medical College of Lanzhou University, Lanzhou, Gansu Province, China

Correspondence Address:
Xiao-Guang Yang
Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan, Gansu Province
China

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).


How to cite this article:
Yang XG, Wang YZ. 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.Clin Trials Orthop Disord 2019;4:34-40


How to cite this URL:
Yang XG, Wang YZ. 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. Clin Trials Orthop Disord [serial online] 2019 [cited 2019 Aug 25 ];4:34-40
Available from: http://www.clinicalto.com/article.asp?issn=2542-4157;year=2019;volume=4;issue=2;spage=34;epage=40;aulast=Yang;type=0