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CERTiFy: Cerament Treatment of Fracture Defects

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Completed
CT.gov ID
NCT01828905
Collaborator
(none)
137
Enrollment
16
Locations
2
Arms
69
Duration (Months)
8.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CERAMENT™|BONE VOID FILLER
  • Procedure: Autologous cancellous bone graft
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 24, 2017
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cerament

CERAMENT™|BONE VOID FILLER as bone graft substitute

Device: CERAMENT™|BONE VOID FILLER
ceramic bone void filler
Active Comparator: Bone graft

Autologous cancellous bone graft (iliac crest)

Procedure: Autologous cancellous bone graft
autologous cancellous bone graft

Outcome Measures

Primary Outcome Measures

  1. SF-12 Physical Component Summary (PCS) at week 26 [26 weeks]

  2. Global pain VAS score at week 26 [26 weeks]

Secondary Outcome Measures

  1. Utilisation of costs of care related resources [26 weeks]

  2. SF-12 PCS and MCS at visit 4 [1 week]

  3. Bone healing [1, 6, 12 and 26 weeks]

    Evaluated by X-ray

  4. SF-12 PCS and MCS at visit 5 [6 weeks]

  5. SF-12 PCS and MCS at visit 6 [12 weeks]

  6. SF-12 PCS and MCS at visit 7 [26 weeks]

Other Outcome Measures

  1. Occurence of adverse events, device complaints and device-related incidents [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Clinic and Polyclinic for Trauma Surgery, Technical University München (Klinikum rechts der Isar) München Bavaria Germany 81675
2 Clinic of Orthopaedics and Trauma Surgery, University Clinics of Freiburg Freiburg Geogr. Baden-Wuerttemberg Germany 79106
3 Clinic of Orthopaedics and Trauma Surgery, Hochtaunus-Kliniken gGmbH Bad Homburg Hesse Germany 61348
4 Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics of Frankfurt Frankfurt Hesse Germany 60590
5 Clinic of Orthopaedics and Trauma Surgery, Clinics of Fulda Fulda Hesse Germany 36043
6 Clinic of Trauma, Hand and Reconstructive Surgery, Healthcare Centre of Rüsselsheim (Gesundheits- und Pflegezentrum, GPR) Rüsselsheim Hesse Germany 65428
7 Clinic of Trauma, Hand and Reconstructive Surgery, University Clinics RWTH Aachen Northrhine-Westfalia Germany 52074
8 Clinic of Orthopaedics and Trauma Surgery, University Clinics of Cologne Cologne Northrhine-Westfalia Germany 50937
9 Clinic of Orthopaedics and Trauma Surgery, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) Duisburg Northrhine-Westfalia Germany 47249
10 Clinic of Trauma and Hand Surgery, University Clinics Düsseldorf Düsseldorf Northrhine-Westfalia Germany 40225
11 Clinic of Trauma, Hand and Reconstructive Surgery Münster Northrhine-Westfalia Germany 48149
12 Centre for Trauma Surgery and Orthopaedics, Stiftungsklinikum Mittelrhein Koblenz Rhineland-Palatinate Germany 56068
13 Clinic of Trauma Surgery and Orthopaedics, Occupational Accident Clinic (Berufsgenossenschaftliche Unfallklinik) Ludwigshafen Rhineland-Palatinate Germany 67071
14 Centre for Trauma surgery, Orthopaedics and Hand Surgery, Clinics of Worms Worms Rhineland-Palatinate Germany 67550
15 Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz Mainz Rhineland-Palatine Germany 55131
16 Clinics of Musculoskeletal Surgery and Laboratory for Biomechanics, University of Schleswig-Holstein, Campus of Lübeck Lübeck Schleswig-Holstein Germany 23538

Sponsors and Collaborators

  • Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Pol M. Rommens, Univ.-Prof., MD, Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

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
Other Study ID Numbers:
  • S041/2012
First Posted:
Apr 11, 2013
Last Update Posted:
Mar 4, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Univ.-Prof. Pol M. Rommens, Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery, 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

Study Results

No Results Posted as of Mar 4, 2019