N/A
N=30
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Tibial Fractures · Intra-Articular Fractures · Fracture Fixation, Internal
Bottom Line
View on ClinicalTrials.gov: NCT02456194 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Sep 2023
Primary outcome: Primary: Resorption of Study Device — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcium Sulfate + Antibiotics + Internal Fixation (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ross Leighton
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resorption of Study Device |
— | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Pain Subscale |
75.38 | — |
| SECONDARY Range of Motion |
126.51 | — |
| SECONDARY Subsidence of Joint Surface |
4 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Pain Subscale |
75.38 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Pain Subscale |
75.38 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Pain Subscale |
75.38 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Pain Subscale |
75.38 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale |
70.69 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale |
70.69 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale |
70.69 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale |
70.69 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale |
70.69 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale |
81.68 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale |
81.68 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale |
81.68 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale |
81.68 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale |
81.68 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale |
53.5 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale |
53.5 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale |
53.5 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale |
53.5 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale |
53.5 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale |
58.98 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale |
58.98 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale |
58.98 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale |
58.98 | — |
| SECONDARY Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale |
58.98 | — |
| SECONDARY Range of Motion |
126.51 | — |
| SECONDARY Range of Motion |
126.51 | — |
| SECONDARY Range of Motion |
126.51 | — |
| SECONDARY Resorption of Study Device |
— | — |
| SECONDARY Resorption of Study Device |
— | — |
| SECONDARY Resorption of Study Device |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02456194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.