Depressed Tibial Plateau FracturesNCT04807062

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

A study testing surgery in people with Depressed Tibial Plateau Fractures, run by Hebei Medical University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depressed Tibial Plateau Fractures
What is being tested?: surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteChina
Study dates: 1 Jan 2016to 1 Aug 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official title: 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.

Conditions: Depressed Tibial Plateau Fractures
Being tested: surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

surgeryProcedure or surgery
Also called Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method
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.

Study groups in NCT04807062
Study group	Role	What they receive
DTPFs treated with structural bicortical autologous ICBG combined with TBTM	Experimental	Not described Receives: Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: up to 2 weeks

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20161 Aug 2020

First posted19 Mar 2021
Study start1 Jan 2016
Primary completion1 Feb 2018
Study completion1 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Depressed Tibial Plateau FracturesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04807062
Sponsor's protocol ID: ICBG001
Status last verified: Mar 2021
First submitted: 16 Mar 2021
Last updated: 19 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method for depressed tibial plateau fractures

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.
PubMed 32897401
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.
PubMed 20881634
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.
PubMed 32131684
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.
PubMed 22159859
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.
PubMed 30206655
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.
PubMed 39428517

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures
ClinicalTrials.gov ID: NCT04807062
Acronym / sponsor ID: ICBG001
Conditions: Depressed Tibial Plateau Fractures
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Hebei Medical University Third HospitalUniversity, hospital or other
Study start: 1 Jan 2016 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 1 Aug 2020 (actual)
First posted: 19 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DTPFs treated with structural bicortical autologous ICBG combined with TBTM	Experimental	Procedure: surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

open fracture;
pathologic fractures;
bone metabolic disease;
previous ICBG;
infection or soft tissue injury of the iliac bone donor site;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
surgeryAlso: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps methodtunnel 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.	Procedure or surgery	DTPFs treated with structural bicortical autologous ICBG combined with TBTM

Primary outcome

Postoperative immediate reduction rate
Time frame: up to 2 weeks
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
Time frame: up to 2 weeks
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
Time frame: up to 2 weeks
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.

6 secondary outcomes

operative time
Time frame: up to 1 weeks
intraoperative blood loss
Time frame: up to 1 weeks
The incidence of complications in the bone-graft donor and bone-graft sites
Time frame: up to 1 weeks
the Visual Analog Scale scores of ICBG donor and bone-graft sites
Time frame: up to 1 week
Hospital for Special Surgery score of knee
Time frame: uo to 1 week
36-Item Short-Form Health Survey score
Time frame: up to 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
Results publication: PubMed 32897401Wang 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 publication: PubMed 20881634Luo 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 publication: PubMed 32131684Greimel 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 publication: PubMed 22159859Myeroff 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 publication: PubMed 30206655Adams 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.
Derived from this study: PubMed 39428517Li 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.
Individual participant dataSharing planned: Yes. Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method for depressed tibial plateau fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chen Wei, Doctor principal investigator

Hebei Medical University Third Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing surgery in people with Depressed Tibial Plateau Fractures, run by Hebei Medical University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative immediate reduction rate (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04807062, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.