Trials / Completed
CompletedNCT02820363
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- BONESUPPORT AB · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™\|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures of the tibial diaphysis.
Detailed description
CERAMENT™\|G is a resorbable, gentamicin containing ceramic bone graft indicated to fill bony voids or gaps which are not intrinsic to the stability of the bony structure and where there is risk of bacterial contamination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CERAMENT|G | Surgical repair of tibia fracture, CERAMENT™\|G applied to bony voids. |
| PROCEDURE | SOC treatment | surgical repair of tibial fracture |
Timeline
- Start date
- 2017-02-14
- Primary completion
- 2021-07-31
- Completion
- 2021-07-31
- First posted
- 2016-07-01
- Last updated
- 2021-08-10
Locations
31 sites across 4 countries: United States, Germany, Poland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02820363. Inclusion in this directory is not an endorsement.