Pseudoarthrosis of Bone
Conditions
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.
Interventions
DEVICEbioglass (S53P4)
surgical procedure: Masquelet defect augmentation with bioglass
DEVICERIA and TCP
surgical procedure: Masquelet defect augmentation with RIA and TCP
Sponsors
Bonalive Biomaterials Ltd
Sebastian Findeisen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants with osseus consolidation evaluation via x-ray | 1 year post-operative Masquelet step II | x-ray in 2 planes; union = cortical bridging of at least three out of four cortices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants with osseus consolidation evaluation via CT | 1 year post-operative Masquelet step II | union = cortical bridging of at least three out of four cortices |
| 12-item Short Form Survey (SF-12) | 1 year post-operative Masquelet step II | Quality of life: Physical Score 23.99938(lowest/worst)-56.57706(highest/best), Mental Score 19.06444(lowest/worst)-60.75781 (highest/best) |
| Perfusion | 3 months post-operative Masquelet step II | 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 |
Countries
Germany
Contacts
Primary ContactSebastian Findeisen, Dr. med.
Backup ContactPatrick Haubruck, Dr. med.
Outcome results
None listed