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Completed

NCT Number: NCT02456194

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

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.

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Key information

Conditions

Tibial Fractures Fracture Fixation, Internal Fractures, Bone Intra-Articular Fractures Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Health Services, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Calcium Sulfate + Antibiotics + Internal Fixation

Device

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.

Other names: STIMULAN Rapid Cure

Primary outcomes

  1. Resorption of Study Device

    Time frame: 6 months

    Number of participants with any study device remaining visible on CT

Secondary outcomes

  1. Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Time frame: Baseline

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  2. Range of Motion

    Time frame: 6 weeks

    Range of knee motion (active flexion) in degrees

  3. Subsidence of Joint Surface

    Time frame: 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.

  4. Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Time frame: 6 weeks

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  5. Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Time frame: 3 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  6. Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Time frame: 6 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  7. Knee Injury Osteoarthritis Outcome Score - Pain Subscale

    Time frame: 12 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  8. Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale

    Time frame: Baseline

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  9. Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale

    Time frame: 6 weeks

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  10. Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale

    Time frame: 6 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  11. Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale

    Time frame: 3 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  12. Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale

    Time frame: 12 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  13. Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale

    Time frame: Baseline

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  14. Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale

    Time frame: 6 weeks

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  15. Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale

    Time frame: 3 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  16. Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale

    Time frame: 6 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  17. Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale

    Time frame: 12 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  18. Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale

    Time frame: Baseline

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  19. Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale

    Time frame: 6 weeks

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  20. Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale

    Time frame: 3 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  21. Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale

    Time frame: 6 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  22. Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale

    Time frame: 12 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  23. Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale

    Time frame: Baseline

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  24. Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale

    Time frame: 6 weeks

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  25. Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale

    Time frame: 3 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  26. Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale

    Time frame: 6 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  27. Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale

    Time frame: 12 months

    Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

  28. Range of Motion

    Time frame: 3 months

    Range of knee motion (active flexion) in degrees

  29. Range of Motion

    Time frame: 6 months

    Range of knee motion (active flexion) in degrees

  30. Range of Motion

    Time frame: 12 months

    Range of knee motion (active flexion) in degrees

  31. Resorption of Study Device

    Time frame: 3 months

    Number of participants with any study device remaining visible on x-ray

  32. Resorption of Study Device

    Time frame: 6 months

    Number of participants with any study device remaining visible on x-ray

  33. Resorption of Study Device

    Time frame: 12 months

    Number of participants with any study device remaining visible on x-ray

Sponsors and collaborators

Lead sponsor

Ross Leighton

Other

Collaborators

  • Biocomposites Ltd

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
May 28, 2015
Registry last updated
Sep 21, 2023

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.

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