Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    Sebastian Findeisen
Updated on 27 September 2021

Summary

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.

Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery.

Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.

Details
Condition Pseudoarthrosis of Bone
Treatment bioglass (S53P4), RIA and TCP
Clinical Study IdentifierNCT05049915
SponsorSebastian Findeisen
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

pseudarthrosis of the tibia or femur
bone defect < 5 cc
surgical treatment with Masquelet technique

Exclusion Criteria

age under 18
disagreement
patients who require amputation of the affected limb
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