Cerament Treatment of Fracture Defects (CERTiFy)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Univ.-Prof. Pol M. Rommens, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01828905
First received: April 4, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
AO 41-B2 and AO 41-B3 Tibia Fractures
Device: CERAMENT™|BONE VOID FILLER
Procedure: Autologous cancellous bone graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • SF-12 Physical Component Summary (PCS) at week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Global pain VAS score at week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Utilisation of costs of care related resources [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • SF-12 PCS and MCS at visit 4 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Bone healing [ Time Frame: 1, 6, 12 and 26 weeks ] [ Designated as safety issue: No ]
    Evaluated by X-ray

  • SF-12 PCS and MCS at visit 5 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • SF-12 PCS and MCS at visit 6 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF-12 PCS and MCS at visit 7 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Occurence of adverse events, device complaints and device-related incidents [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 136
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cerament
CERAMENT™|BONE VOID FILLER as bone graft substitute
Device: CERAMENT™|BONE VOID FILLER
Active Comparator: Bone graft
Autologous cancellous bone graft (iliac crest)
Procedure: Autologous cancellous bone graft

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828905

Contacts
Contact: Pol M. Rommens, Univ.-Prof. +49-6131-177292 pol.rommens@unimedizin-mainz.de
Contact: Alexander Hofmann, PD MD +49-6131-176112 Hofmann.Trauma-Surgery@gmx.net

Locations
Germany
Department of Trauma Surgery, Center for Musculoskeletal Surgery, Johannes Gutenberg University Mainz Recruiting
Mainz, Rhineland-Palatine, Germany, 55131
Contact: Pol M. Rommens, Univ.-Prof.    +49-6131-177292    pol.rommens@unimedizin-mainz.de   
Contact: Alexander Hofmann, PD MD    +49-6131-176112    Hofmann.Trauma-Surgery@gmx.net   
Principal Investigator: Pol M. Rommens, Univ.-Prof.         
Sub-Investigator: Alexander Hofmann, PD MD         
Sub-Investigator: Thomas Nusselt, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Univ.-Prof. Pol M. Rommens, Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01828905     History of Changes
Other Study ID Numbers: S041/2012
Study First Received: April 4, 2013
Last Updated: March 12, 2014
Health Authority: Germany: Ethics Committee Rhineland-Palatinate

Keywords provided by Johannes Gutenberg University Mainz:
tibia fracture
bone graft
iliac crest
bone graft substitute
Cerament
void filler
quality of life
pain
costs of care

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014