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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013882

Enrollment

Registered

2018-01-22

Start date

2018-05-31

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M84.15 M84.16

Interventions

Group 1: Intervention group: Patients suffering from a non-union of the tibia or femur treated with the Masquelet-therapy using 100% bioactive glass (S53P4) in the second step of treatment. Group 2: C

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Osseous union achieved 12 months subsequent to treatment	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactPatrick Haubruck

Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Heidelberg, Abteilung für Unfallchirurgie

patrick.haubruck@med.uni-heidelberg.de004962215626398

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026