Antibiotic Loaded Calcium Sulfate RCT

NCT03875963 | Terminated

• 1 other identifier: 5148
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.

Conditions

Fracture Non Union; Infection

Keywords

Infection; Antibiotic bone cement; Tibia nonunion

Outcome Measures

Primary Outcomes (1)

• Number of re-operations

  Number of re-operations to obtain union or manage malunion, implant failure, or to eradicate infection.

  2 years post-injury

Secondary Outcomes (7)

• Numeric Pain Rating Scale

  Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

• Functional Index In Trauma (FIX-IT) Measure

  Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

• Patient reported outcomes

  Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

• EuroQol Group Quality of Life Scale with 5 Dimensions and 5 Levels (EQ-5D-5L)

  Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

• Number of patients with complications

  Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Study Arms (2)

Antibiotic loaded bone filler

EXPERIMENTAL

Patients will undergo irrigation and debridement, surgical stabilization as required, and defect management by placement of antibiotic loaded Stimulan as a bone void filler \[calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin\]. The concurrent use of antibiotics is at the discretion of the treating physician.

Other: Antibiotic loaded bone filler

Standard of care

NO INTERVENTION

Current standard of care treatment for infected tibial defects or infected tibial nonunions includes treatment with irrigation and debridement, surgical stabilization as required, and defect management as required including placement of a polymethyl methacrylate spacer with or without antibiotics. A second procedure may or may not occur 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. Concurrent use of antibiotics is at the discretion of the treating physician.

Interventions

Antibiotic loaded bone filler OTHER

Defect management by placement of antibiotic loaded Stimulan as a bone void filler \[calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin\].

Antibiotic loaded bone filler

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥16 years old.
• Isolated infected tibia defect or infected tibial nonunion (characterized by clinical symptoms present for greater than 90 days, the presence of necrotic bone, and bacteria cultured from prior procedures, surgical biopsy, or draining sinuses).

You may not qualify if:

• Presence of previous vascular injury or pathologic fracture
• Associated lower limb injuries that would interfere with rehabilitation or outcome
• Refusal to participate
• Inability to provide informed consent
• Inability to speak/understand or read English without a registered interpreter.
• Allergy or sensitivity to Vancomycin or Tobramycin

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Biocomposites Ltd: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (10)

• PELTIER LF. The use of plaster of paris to fill large defects in bone. Am J Surg. 1959 Mar;97(3):311-5. doi: 10.1016/0002-9610(59)90305-8. No abstract available.

  PMID: 13627355 BACKGROUND

• PELTIER LF. The use of plaster of Paris to fill defects in bone. Clin Orthop. 1961;21:1-31. No abstract available.

  PMID: 14485018 BACKGROUND

• PELTIER LF, BICKEL EY, LILLO R, THEIN MS. The use of plaster of paris to fill defects in bone. Ann Surg. 1957 Jul;146(1):61-9. doi: 10.1097/00000658-195707000-00007. No abstract available.

  PMID: 13435702 BACKGROUND

• Peltier LF, Jones RH. Treatment of unicameral bone cysts by curettage and packing with plaster-of-Paris pellets. J Bone Joint Surg Am. 1978 Sep;60(6):820-2.

  PMID: 701318 BACKGROUND

• KOVACEVIC B. [Problem of hematogenous osteomyelitis]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1953;276:432-43. No abstract available. Undetermined Language.

  PMID: 13143827 BACKGROUND

• Fischer G, Seidler W. [Results in the treatment of osteomyelitic bone cavities using antibiotic gypsum medullary plombage]. Dtsch Gesundheitsw. 1971 Nov 4;26(45):2105-7. No abstract available. German.

  PMID: 5145654 BACKGROUND

• McKee MD, Li-Bland EA, Wild LM, Schemitsch EH. A prospective, randomized clinical trial comparing an antibiotic-impregnated bioabsorbable bone substitute with standard antibiotic-impregnated cement beads in the treatment of chronic osteomyelitis and infected nonunion. J Orthop Trauma. 2010 Aug;24(8):483-90. doi: 10.1097/BOT.0b013e3181df91d9.

  PMID: 20657257 BACKGROUND

• McKee MD, Wild LM, Schemitsch EH, Waddell JP. The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma. 2002 Oct;16(9):622-7. doi: 10.1097/00005131-200210000-00002.

  PMID: 12368641 BACKGROUND

• Gauland C. Managing lower-extremity osteomyelitis locally with surgical debridement and synthetic calcium sulfate antibiotic tablets. Adv Skin Wound Care. 2011 Nov;24(11):515-23. doi: 10.1097/01.ASW.0000407647.12832.6c.

  PMID: 22015750 BACKGROUND

• Jogia RM, Modha DE, Nisal K, Berrington R, Kong MF. Use of highly purified synthetic calcium sulfate impregnated with antibiotics for the management of diabetic foot ulcers complicated by osteomyelitis. Diabetes Care. 2015 May;38(5):e79-80. doi: 10.2337/dc14-3100. No abstract available.

  PMID: 25908163 BACKGROUND

MeSH Terms

Conditions

Fractures, Ununited; Infections

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Emil Schemitsch, MD FRCS(C)

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Determination of union assessed by two independent assessors blinded to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is a multi-centered, prospective, randomized controlled trial, comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: January 1, 2020
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)