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

NCT ID: NCT04807062

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressed Tibial Plateau Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DTPFs treated with structural bicortical autologous ICBG combined with TBTM

Group Type EXPERIMENTAL

surgery

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chen Wei, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Third Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 32897401 (View on PubMed)

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.

Reference Type RESULT
PMID: 20881634 (View on PubMed)

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.

Reference Type RESULT
PMID: 32131684 (View on PubMed)

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.

Reference Type RESULT
PMID: 22159859 (View on PubMed)

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.

Reference Type RESULT
PMID: 30206655 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39428517 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICBG001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.