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

Sebastian Findeisen

Status: Unknown

Conditions: Pseudoarthrosis of Bone

Treatments: Device: bioglass (S53P4); Device: RIA and TCP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05049915

S-472/2017

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Masquelet technique: bioactive glass

Experimental group

Treatment:

Device: bioglass (S53P4)

Masquelet technique: RIA + TCP

Active Comparator group

Treatment:

Device: RIA and TCP