Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456194

Enrollment

Registered

2015-05-28

Start date

2015-09-30

Completion date

2021-05-31

Last updated

2023-09-21

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

Conditions

Fracture Fixation, Internal, Intra-Articular Fractures, Tibial Fractures

Brief summary

This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the study device. Our primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.

Interventions

DEVICECalcium Sulfate + Antibiotics + Internal Fixation

STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Adult (skeletally mature) men or women; * Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5; * Internal fixation and use of study device per protocol; * Fracture repair within 30 days of injury; * Signed informed consent to participate in study.

Exclusion criteria

* Uncontrolled diabetes; * Severe degenerative or metabolic bone disease; * Malignancy; * Severe vascular or neurologic disease; * Alcoholism; * Substance abuse; * Use of systemic steroids; * Immunosuppressive therapy; * Hypercalcaemia; * Renal-compromised patients; * Osteomyelitis or chronic infection in the study limb; * Women who are pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame	Description
Resorption of Study Device	6 months	Number of participants with any study device remaining visible on CT

Secondary

Measure	Time frame	Description
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Baseline	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Range of Motion	6 weeks	Range of knee motion (active flexion) in degrees
Subsidence of Joint Surface	6 weeks, 3 months, 6 months, 12 months	Amount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.
Resorption of Study Device	3 months	Number of participants with any study device remaining visible on x-ray
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Baseline	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Baseline	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Baseline	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Baseline	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Calcium Sulfate + Antibiotics + Internal Fixation Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.	30
Total	30

Baseline characteristics

Characteristic	Calcium Sulfate + Antibiotics + Internal Fixation	—
Age, Continuous	53.3 years STANDARD_DEVIATION 12.8	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	30 participants	—
Sex: Female, Male Female	17 Participants	—
Sex: Female, Male Male	13 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	6 / 30
serious Total, serious adverse events	1 / 30

Outcome results

Primary

Resorption of Study Device

Number of participants with any study device remaining visible on CT

Time frame: 6 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Calcium Sulfate + Antibiotics + Internal Fixation	Resorption of Study Device	4 Participants

Secondary