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

NCT04807062 | Completed

• 1 other identifier: ICBG001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressed Tibial Plateau Fractures

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• operative time

  up to 1 weeks

• intraoperative blood loss

  up to 1 weeks

• The incidence of complications in the bone-graft donor and bone-graft sites

  up to 1 weeks

• the Visual Analog Scale scores of ICBG donor and bone-graft sites

  up to 1 week

• Hospital for Special Surgery score of knee

  uo to 1 week

Study Arms (1)

DTPFs treated with structural bicortical autologous ICBG combined with TBTM

EXPERIMENTAL

Procedure: surgery

Interventions

surgery PROCEDURE

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.

Also known as: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method

DTPFs treated with structural bicortical autologous ICBG combined with TBTM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Related Publications (6)

• 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.

  PMID: 32897401 RESULT

• 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.

  PMID: 20881634 RESULT

• 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.

  PMID: 32131684 RESULT

• 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.

  PMID: 22159859 RESULT

• 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.

  PMID: 30206655 RESULT

• Li Y, Yang S, Yang H, Lian X, Hou Z. Drain versus no-drain at the donor sites of iliac crest bone graft: a retrospective study. J Orthop Surg Res. 2024 Oct 21;19(1):675. doi: 10.1186/s13018-024-05147-3.

  PMID: 39428517 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Chen Wei, Doctor

  Hebei Medical University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years after the experiment was conducted
• Access Criteria: all authors focusing on tibial plateau fractures

Locations

CN (1)