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Completed

NCT Number: NCT04807062

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

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.

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Key information

Conditions

Depressed Tibial Plateau Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. operative time

    Time frame: up to 1 weeks

    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.

  2. intraoperative blood loss

    Time frame: up to 1 weeks

    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.

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

    Time frame: up to 1 weeks

    Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes.

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

    Time frame: up to 1 week

    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.

  5. Hospital for Special Surgery score of knee

    Time frame: uo to 1 week

    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.

  6. 36-Item Short-Form Health Survey score

    Time frame: up to 1 week

    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.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.