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

Pseudoarthrosis of Bone Clinical Trial

Official title:

Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Non-unions of the Tibia and Femur: a Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049915
• Other study ID #: S-472/2017
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University Hospital Heidelberg
• Contact: Sebastian Findeisen, Dr. med.
• Phone: +4962215634330
• Email: sebastian.findeisen[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pseudarthrosis
• Pseudoarthrosis of Bone

Intervention

Device:
• bioglass (S53P4)
surgical procedure: Masquelet defect augmentation with bioglass
• RIA and TCP
surgical procedure: Masquelet defect augmentation with RIA and TCP

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Sebastian Findeisen	Bonalive Biomaterials Ltd

Country where clinical trial is conducted

Germany, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participants with osseus consolidation evaluation via x-ray	x-ray in 2 planes; union = cortical bridging of at least three out of four cortices	1 year post-operative Masquelet step II
Secondary	12-item Short Form Survey (SF-12)	Quality of life: Physical Score 23.99938(lowest/worst)-56.57706(highest/best), Mental Score 19.06444(lowest/worst)-60.75781 (highest/best)	1 year post-operative Masquelet step II
Secondary	Perfusion	Real-time microperfusion assessment using Contrast enhanced ultra-sound (CEUS), contrasting agent: SonoVue. Objective perfusion quantification (using VueBox). Evaluation of characteristic perfusion parameters such as: wash-in rate, wash-in perfusion index	3 months post-operative Masquelet step II
Secondary	Rate of participants with osseus consolidation evaluation via CT	union = cortical bridging of at least three out of four cortices	1 year post-operative Masquelet step II