Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04807062
Enrollment
47
Registered
2021-03-19
Start date
2016-01-01
Completion date
2020-08-01
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressed Tibial Plateau Fractures

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.

Interventions

PROCEDUREsurgery

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.

Sponsors

Hebei Medical University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative immediate reduction rateup to 2 weeksPreoperative 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 rateup to 2 weeksThe 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 timeup to 2 weeksPostoperative 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

MeasureTime frameDescription
the Visual Analog Scale scores of ICBG donor and bone-graft sitesup to 1 weekThe 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.
operative timeup to 1 weeksThe 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.
36-Item Short-Form Health Survey scoreup to 1 week36-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.
Hospital for Special Surgery score of kneeuo to 1 weekThe 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.
intraoperative blood lossup to 1 weeksThe 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 sitesup to 1 weeksSurging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026