Clinical trial NCT05049915: Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pseudoarthrosis of Bone
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Bonalive Biomaterials Ltd
First posted: 2021-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of participants with osseus consolidation evaluation via x-ray
timeFrame: 1 year post-operative Masquelet step II
Secondary outcomes:
measure: 12-item Short Form Survey (SF-12)
timeFrame: 1 year post-operative Masquelet step II
measure: Perfusion
timeFrame: 3 months post-operative Masquelet step II
measure: Rate of participants with osseus consolidation evaluation via CT
timeFrame: 1 year post-operative Masquelet step II
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: HTRG
name: Gerhard Schmidmaier, Prof. Dr.
role: STUDY_DIRECTOR
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