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

Primary Purpose

Depressed Tibial Plateau Fractures

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
surgery
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressed Tibial Plateau Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Third Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DTPFs treated with structural bicortical autologous ICBG combined with TBTM

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 16, 2021
Last Updated
March 17, 2021
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04807062
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressed Tibial Plateau Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DTPFs treated with structural bicortical autologous ICBG combined with TBTM
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative immediate reduction rate
Description
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.
Time Frame
up to 2 weeks
Title
Postoperative long-term reduction rate
Description
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.
Time Frame
up to 2 weeks
Title
Bone healing time
Description
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.
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
operative time
Description
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.
Time Frame
up to 1 weeks
Title
intraoperative blood loss
Description
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.
Time Frame
up to 1 weeks
Title
The incidence of complications in the bone-graft donor and bone-graft sites
Description
Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes.
Time Frame
up to 1 weeks
Title
the Visual Analog Scale scores of ICBG donor and bone-graft sites
Description
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.
Time Frame
up to 1 week
Title
Hospital for Special Surgery score of knee
Description
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.
Time Frame
uo to 1 week
Title
36-Item Short-Form Health Survey score
Description
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.
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wei, Doctor
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32897401
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.
Results Reference
result
PubMed Identifier
20881634
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.
Results Reference
result
PubMed Identifier
32131684
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.
Results Reference
result
PubMed Identifier
22159859
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.
Results Reference
result
PubMed Identifier
30206655
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.
Results Reference
result

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

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