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Cerament Treatment of Fracture Defects (CERTiFy)

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ClinicalTrials.gov Identifier: NCT01828905
Recruitment Status : Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz

April 4, 2013
April 11, 2013
August 9, 2018
April 2013
December 24, 2017   (Final data collection date for primary outcome measure)
  • SF-12 Physical Component Summary (PCS) at week 26 [ Time Frame: 26 weeks ]
  • Global pain VAS score at week 26 [ Time Frame: 26 weeks ]
Same as current
Complete list of historical versions of study NCT01828905 on ClinicalTrials.gov Archive Site
  • Utilisation of costs of care related resources [ Time Frame: 26 weeks ]
  • SF-12 PCS and MCS at visit 4 [ Time Frame: 1 week ]
  • Bone healing [ Time Frame: 1, 6, 12 and 26 weeks ]
    Evaluated by X-ray
  • SF-12 PCS and MCS at visit 5 [ Time Frame: 6 weeks ]
  • SF-12 PCS and MCS at visit 6 [ Time Frame: 12 weeks ]
  • SF-12 PCS and MCS at visit 7 [ Time Frame: 26 weeks ]
Same as current
Occurence of adverse events, device complaints and device-related incidents [ Time Frame: 26 weeks ]

Frequencies of subjects experiencing at least one adverse event (AE) will be displayed by body system and preferred term according to MedDRA terminology. Detailed information collected for each AE will include: a description of the event, duration, whether the AE was serious, intensity, relationship to trial device, action taken, clinical outcome. Summary tables will present the number of subjects observed with AEs and corresponding percentages.

Number of device complaints and device-related incidents (AE related to the trial device) respectively as well as the frequencies of occurences of these events in both groups will be calculated.

Same as current
 
Cerament Treatment of Fracture Defects
A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
AO 41-B2 and AO 41-B3 Tibia Fractures
  • Device: CERAMENT™|BONE VOID FILLER
    ceramic bone void filler
  • Procedure: Autologous cancellous bone graft
    autologous cancellous bone graft
  • Experimental: Cerament
    CERAMENT™|BONE VOID FILLER as bone graft substitute
    Intervention: Device: CERAMENT™|BONE VOID FILLER
  • Active Comparator: Bone graft
    Autologous cancellous bone graft (iliac crest)
    Intervention: Procedure: Autologous cancellous bone graft
Nusselt T, Hofmann A, Wachtlin D, Gorbulev S, Rommens PM. CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures. Trials. 2014 Mar 8;15:75. doi: 10.1186/1745-6215-15-75.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
137
136
December 31, 2018
December 24, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01828905
S041/2012
No
Not Provided
Not Provided
Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
Not Provided
Principal Investigator: Pol M. Rommens, Univ.-Prof., MD Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP