Minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for repair of distal radius fracture: study protocol for a randomized controlled trial
10.3969/j.issn.2095-4344.2017.31.014
- VernacularTitle:微创闭合复位全螺纹空心螺钉内固定修复桡骨远端骨折稳定性研究:随机对照临床试验方案
- Author:
feng Li YANG
1
;
Yang ZHANG
;
Nan WANG
;
Ji MA
;
Zhi LI
Author Information
1. 沈阳医学院附属中心医院骨外科
- From:
Chinese Journal of Tissue Engineering Research
2017;21(31):5001-5006
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: Conventional open reduction internal fixation and external fixation are not ideal treatment options for distal radius fracture. Minimally invasive surgery for distal radius fracture results in less trauma than other techniques;fully threaded headless cannulated compression screws can increase the stability of fracture fragments and contribute to functional recovery after wrist fracture. Our previous studies have found that minimally invasive closed reduction and internal fixation of distal radius fracture with fully threaded headless cannulated compression screws obtains satisfactory curative efficacy, especially for fracture involving the wrist joint, but no more than two fracture fragments.OBJECTIVE: We hypothesized that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws provides better stability than conventional methods, and can effectively promote the early recovery of wrist function.METHODS: In this prospective, randomized, controlled trial, we will recruit 60 outpatients with distal radius fracture from the Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, China. Patients will be assigned to one of two treatment groups: C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws (experimental group) or open reduction (palmar and dorsal incisions) and internal fixation with titanium plate (control group). Internal fixation will be maintained for 24 weeks in both groups. Our primary outcome measure will be X-ray and CT examinations 24 weeks after surgery.Secondary measures include patient-rated wrist evaluation scores, used to evaluate wrist joint function; fracture healing time; and Visual Analogue Scale score, used to evaluate the severity of the patient's pain. This trial has been registered at ClinicalTrials.gov (identifier: NCT02784678). The study protocol has been approved by the Ethics Committee of Central Hospital Affiliated to Shenyang Medical College, China. The trial protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association (General Assembly of the World Medical Association, 2014).DISCUSSION: With this study, we hope to confirm that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for distal radius fracture repair has advantages over conventional open reduction internal fixation with titanium plates, providing superior fragment stability and allowing for early rehabilitation exercise of the wrist joint, which improves recovery of function. We hope to show that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws is suitable surgical method for repair of distal radius fracture.
