Treatment of Tibial Plateau Fractures With Bone-graft and Bone Tamp Technique

Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures

Autologous ICBG and bone tamp methods are often applied to manage depressed tibial plateau fracture (DTPF), but previous iliac bone harvesting and bone tamp techniques remain controversial. The purpose of this study is to describe and evaluate the technique of using structural bicortical autologous iliac crest bone-graft (ICBG) combined with tunnel bone tamps method (TBTM) in treating DTPFs.

Study Overview

• Status: Completed
• Conditions: Depressed Tibial Plateau Fractures
• Intervention / Treatment: Procedure: surgery

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Third Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients (age ≥ 18 years);
• diagnosis of DTPFs;
• agreeing to receive structural bicortical autologous ICBG combined with TBTM treatment and subsequent internal fixation treatment;
• agreeing to participate in regular follow-up after surgery.

Exclusion Criteria:

• open fracture;
• pathologic fractures;
• bone metabolic disease;
• previous ICBG;
• infection or soft tissue injury of the iliac bone donor site;
• pelvic fractures or bone tumors;
• associated peripheral nerve injury;
• non-completion of 30 months follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DTPFs treated with structural bicortical autologous ICBG combined with TBTM	Procedure: surgery; tunnel bone tamps method (TBTM) was used to reduce the depressed articular fragments and then structural bicortical autologous ICBG was used to fill the valley tunnel.; Other Names: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative immediate reduction rate	Preoperative and postoperative imaging data of all subjects, including X-ray and CT scans, were collected. Picture Archiving and Communication Systems (PACS) was used to measure articular step-off and evaluate the immediate reduction after surgery.	up to 2 weeks
Postoperative long-term reduction rate	The immediate postoperative and follow-up imaging data of all subjects, including X-ray and CT scan, were collected. PACS system was used to measure the articular step-off and evaluate the long-term reduction after surgery.	up to 2 weeks
Bone healing time	Postoperative follow-up imaging data of all patients were collected, including X-ray and CT scans.Evaluating the bone healing time based on callus growth.	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	The operation time in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma.	up to 1 weeks
intraoperative blood loss	The intraoperative blood loss in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma.	up to 1 weeks
The incidence of complications in the bone-graft donor and bone-graft sites	Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes.	up to 1 weeks
the Visual Analog Scale scores of ICBG donor and bone-graft sites	The Visual Analog Scale pain scores (ranged from 0 to 10, 0 representing no pain and 10 representing maximal imaginable pain) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect.	up to 1 week
Hospital for Special Surgery score of knee	The knee Hospital for Special Surgery scores (ranged from 0 to 100, 0 representing poor knee function and 100 representing normal knee function) of all subjects during the postoperative follow-up was recorded as the basis for evaluating the surgical effect.	uo to 1 week
36-Item Short-Form Health Survey score	36-Item Short-Form Health Survey scores (ranged from 0 to 100, 0 representing poor health and 100 representing normal health) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect.	up to 1 week

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Principal Investigator: Chen Wei, Doctor, Hebei Medical University Third Hospital

Publications and helpful links

General Publications

• Wang Z, Tian S, Zhao K, Zhang R, Yin Y, Zhu Y, Hou Z, Zhang Y. Neutrophil to lymphocyte ratio and fracture severity in young and middle-aged patients with tibial plateau fractures. Int Orthop. 2020 Dec;44(12):2769-2777. doi: 10.1007/s00264-020-04793-6. Epub 2020 Sep 8.
• Luo CF, Sun H, Zhang B, Zeng BF. Three-column fixation for complex tibial plateau fractures. J Orthop Trauma. 2010 Nov;24(11):683-92. doi: 10.1097/BOT.0b013e3181d436f3.
• Greimel F, Weber M, Renkawitz T, Voellner F, Freude T, Grifka J, Craiovan B. Minimally invasive treatment of tibial plateau depression fractures using balloon tibioplasty: Clinical outcome and absorption of bioabsorbable calcium phosphate cement. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(1):2309499020908721. doi: 10.1177/2309499020908721.
• Myeroff C, Archdeacon M. Autogenous bone graft: donor sites and techniques. J Bone Joint Surg Am. 2011 Dec 7;93(23):2227-36. doi: 10.2106/JBJS.J.01513.
• Adams D, Patel JN, Tyagi V, Yoon RS, Liporace F. A simple method for bone graft insertion during Schatzker II and III plateau fixation. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):850-853. doi: 10.1007/s00167-018-5134-9. Epub 2018 Sep 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Depression; Fractures, Bone
• Other Study ID Numbers: ICBG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method for depressed tibial plateau fractures
• IPD Sharing Time Frame: 2 years after the experiment was conducted
• IPD Sharing Access Criteria: all authors focusing on tibial plateau fractures
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No