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

NCT05049915 | Unknown

• 1 other identifier: S-472/2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudoarthrosis of Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 12-item Short Form Survey (SF-12)

  1 year post-operative Masquelet step II

• Perfusion

  3 months post-operative Masquelet step II

• Rate of participants with osseus consolidation evaluation via CT

  1 year post-operative Masquelet step II

Study Arms (2)

Masquelet technique: bioactive glass

EXPERIMENTAL

Device: bioglass (S53P4)

Masquelet technique: RIA + TCP

ACTIVE COMPARATOR

Device: RIA and TCP

Interventions

bioglass (S53P4) DEVICE

surgical procedure: Masquelet defect augmentation with bioglass

Masquelet technique: bioactive glass

RIA and TCP DEVICE

surgical procedure: Masquelet defect augmentation with RIA and TCP

Masquelet technique: RIA + TCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sebastian Findeisen: lead
• Bonalive Biomaterials Ltd: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69118, Germany

RECRUITING

Related Publications (19)

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MeSH Terms

Interventions

Radioimmunoassay

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Radioisotope; Diagnostic Techniques and Procedures; Diagnosis; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques

Study Officials

• Gerhard Schmidmaier, Prof. Dr.

  HTRG

  STUDY DIRECTOR

Central Study Contacts

Sebastian Findeisen, Dr. med.

CONTACT

+4962215634330; sebastian.findeisen@med.uni-heidelberg.de

Patrick Haubruck, Dr. med.

CONTACT

patrick.haubruck@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Intern

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: September 20, 2021
• Study Start: June 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after conclusion and evaluation of the study
• Access Criteria: public

Locations

DE (1)