Clinical trial NCT04807062: Treatment of Tibial Plateau Fractures With Bone-graft and Bone Tamp Technique
Official title: Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressed Tibial Plateau Fractures
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative immediate reduction rate
timeFrame: up to 2 weeks
measure: Postoperative long-term reduction rate
timeFrame: up to 2 weeks
measure: Bone healing time
timeFrame: up to 2 weeks
Secondary outcomes:
measure: operative time
timeFrame: up to 1 weeks
measure: intraoperative blood loss
timeFrame: up to 1 weeks
measure: The incidence of complications in the bone-graft donor and bone-graft sites
timeFrame: up to 1 weeks
measure: the Visual Analog Scale scores of ICBG donor and bone-graft sites
timeFrame: up to 1 week
measure: Hospital for Special Surgery score of knee
timeFrame: uo to 1 week
measure: 36-Item Short-Form Health Survey score
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the Third Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Chen Wei, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.