Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial

Trials, 2018 · DOI: https://doi.org/10.1186/s13063-018-2681-9 · Published: May 10, 2018

Simple Explanation

This study aims to assess if bioactive glass (BaG) is as effective as the current standard treatment, which involves using a bone graft from the patient's own body (autologous bone graft or ABG), for treating non-unions (fractures that don't heal) in the tibia and femur. The Masquelet technique, a two-stage procedure, will be used. First, a membrane is created around the non-union site. Second, the resulting defect is filled with either ABG or BaG. The study will compare the success rates of bone healing between these two groups. The study will also monitor the patients' quality of life, bone graft perfusion, and other factors like smoking status and pre-existing conditions. The goal is to determine if BaG is a suitable alternative to ABG in non-union therapy, potentially reducing complications associated with harvesting ABG.

Study Duration

4 years

Participants

50 patients with tibial or femoral non-unions

Evidence Level

Level 1, Randomized controlled non-inferiority trial

Key Findings

1
The primary endpoint of the study is union achieved 1 year after surgery.
2
The results of the study should, therefore, help investigate the potential benefits and limitations regarding the use of S53P4-BaG in Masquelet therapy.
3
Data from the study will increase the knowledge about S53P4-BaG as a bone graft substitute as well as identify patients who might benefit from Masquelet therapy using this type of BaG and those who are more likely to fail.

Research Summary

This study is a randomized controlled trial designed to evaluate the non-inferiority of bioactive glass (BaG) compared to autologous bone graft (ABG) in treating tibial and femoral non-unions using the Masquelet technique. The primary outcome is bone union at 1 year, with secondary outcomes including quality of life, graft perfusion, and socioeconomic factors. The study aims to determine if BaG is a viable alternative to ABG, potentially reducing complications associated with ABG harvesting and improving non-union treatment outcomes.

Practical Implications

Reduced Morbidity

If BaG is proven non-inferior, it could reduce the need for autologous bone graft harvesting, thus minimizing donor-site morbidity and associated complications.

Improved Patient Outcomes

The study could identify specific patient populations that benefit most from BaG in Masquelet therapy, leading to more personalized and effective treatment strategies.

Cost-Effective Treatment

Successful implementation of BaG could lead to a more cost-effective treatment option for non-unions, reducing the overall healthcare burden.

Study Limitations

1
A potential limitation of the planned study lies in the utilization of different methods of osteosynthesis that might influence the outcome of non-union treatment.
2
Currently, there are no comparable studies available in the academic literature.
3
If initial data indicates either an inferior outcome of patients included into the study group, or an increased risk for patients of the study group that is potentially harmful for patients, the study will be terminated.

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