NCT02456194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

November 1, 2022

Enrollment Period

3.6 years

First QC Date

May 26, 2015

Results QC Date

November 10, 2022

Last Update Submit

November 10, 2022

Conditions

Tibial FracturesIntra-Articular FracturesFracture Fixation, Internal

Outcome Measures

Primary Outcomes (1)

  • Resorption of Study Device

    Number of participants with any study device remaining visible on CT

    6 months

Secondary Outcomes (33)

  • Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Baseline

  • Range of Motion

    6 weeks

  • Subsidence of Joint Surface

    6 weeks, 3 months, 6 months, 12 months

  • Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    6 weeks

  • Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    3 months

  • +28 more secondary outcomes

Study Arms (1)

Calcium Sulfate + Antibiotics + Internal Fixation

EXPERIMENTAL
Device: Calcium Sulfate + Antibiotics + Internal Fixation

Interventions

Calcium Sulfate + Antibiotics + Internal FixationDEVICE

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.

Also known as: STIMULAN Rapid Cure
Calcium Sulfate + Antibiotics + Internal Fixation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alberta Health Services

Calgary, Alberta, T2N 1N4, Canada

Location

Horizon Health Network

Moncton, New Brunswick, E1C6Z8, Canada

Location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1C5S7, Canada

Location

Halifax Infirmary

Halifax, Nova Scotia, B3h 1V7, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

MeSH Terms

Conditions

Tibial FracturesIntra-Articular Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Results Point of Contact

Title
Ross Leighton
Organization
NSHA
Ross.Leighton@nshealth.ca
1-902-473-4035

Study Officials

  • Ross Leighton, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2019

Study Completion

May 1, 2021

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2022-11

Locations

CA(5)