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

Not Applicable

Recruiting

• Conditions: M84.15; M84.16

• Registration Number: DRKS00013882
• Lead Sponsor: Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Heidelberg, Abteilung für Unfallchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients older than 18 years who suffer from tibial or femoral non-unions with a bone defect of 2-5 cm³ and who are receiving Masquelet treatment will be included into the study after giving informed consent.

Exclusion Criteria

Patients who do not agree to participate in the study, who are not able to give informed consent and patients receiving an amputation because of persistent infection or extended soft tissue defects will be excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osseous union achieved 12 months subsequent to treatment<br>

Secondary Outcome Measures

Name	Time	Method
1. Subjective evaluation of the quality of life (assessed by SF-12 questionnaire) and pain (VAS) of affected patients. <br>2. Perfusion of the graft is evaluated and compared between groups. <br>3.Expression patterns of inflammatory and angiogenic cytokines are evaluated during the course of the study and compared between groups regarding possible differences. <br>4. Union achieved two years after surgery <br>5. Possible differences regarding socioeconomic factors are assessed and compared between groups.