Cerament Treatment of Fracture Defects

Not Applicable

Completed

• Conditions: AO 41-B2 and AO 41-B3 Tibia Fractures
• Interventions: Procedure: Autologous cancellous bone graft; Device: CERAMENT™|BONE VOID FILLER

• Registration Number: NCT01828905
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™\|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-11
• Primary Completion: 2017-12-24
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 & B3)
• solitary trauma
• candidate for bone grafting
• patients between the age of 18 and 65 years
• written informed consent obtained before any study-related activities
• patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program

Exclusion Criteria

• patients with multiple injuries
• polytrauma patients
• compartment syndrome
• previous iliac crest bone graft harvesting
• local infection at the site of implantation
• chronic pain disease
• malignancy
• rheumatoid arthritis
• chronic cortisone intake
• X-ray diagnostics not available, fracture cannot be classified
• clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
• a pre-existing calcium metabolism disorder (e.g. hypercalcemia)
• known hyperthyroidism or autonomous thyroid adenoma
• history of serious reaction to iodine based radio contrast agents
• women who are pregnant or breastfeeding
• irreversible coagulopathy or bleeding disorder
• history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications
• history of hypersensitivity to the investigational device or any of its ingredients
• participation in other clinical trials during the present clinical trial or within the last 1 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone graft	Autologous cancellous bone graft	Autologous cancellous bone graft (iliac crest)
Cerament	CERAMENT™|BONE VOID FILLER	CERAMENT™\|BONE VOID FILLER as bone graft substitute

Primary Outcome Measures

Name	Time	Method
SF-12 Physical Component Summary (PCS) at week 26	26 weeks
Global pain VAS score at week 26	26 weeks

Secondary Outcome Measures

Name	Time	Method
SF-12 PCS and MCS at visit 5	6 weeks
Utilisation of costs of care related resources	26 weeks
SF-12 PCS and MCS at visit 4	1 week
Bone healing	1, 6, 12 and 26 weeks	Evaluated by X-ray
SF-12 PCS and MCS at visit 6	12 weeks
SF-12 PCS and MCS at visit 7	26 weeks

Trial Locations

Locations (16)

Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms; 🇩🇪 Worms, Rhineland-Palatinate, Germany

Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH; 🇩🇪 Bad Homburg, Hesse, Germany

Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik); 🇩🇪 Ludwigshafen, Rhineland-Palatinate, Germany

Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein; 🇩🇪 Koblenz, Rhineland-Palatinate, Germany

Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar); 🇩🇪 München, Bavaria, Germany

Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg; 🇩🇪 Freiburg, Geogr. Baden-Wuerttemberg, Germany

Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR); 🇩🇪 Rüsselsheim, Hesse, Germany

Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt; 🇩🇪 Frankfurt, Hesse, Germany

Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda; 🇩🇪 Fulda, Hesse, Germany

Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH; 🇩🇪 Aachen, Northrhine-Westfalia, Germany

Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik); 🇩🇪 Duisburg, Northrhine-Westfalia, Germany

Clinic of Trauma, Hand and Reconstructive Surgery; 🇩🇪 Münster, Northrhine-Westfalia, Germany

Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne; 🇩🇪 Cologne, Northrhine-Westfalia, Germany

Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf; 🇩🇪 Düsseldorf, Northrhine-Westfalia, Germany

Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Rhineland-Palatine, Germany