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Completed

NCT Number: NCT01828905

Cerament Treatment of Fracture Defects

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.

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Key information

Conditions

AO 41-B2 and AO 41-B3 Tibia Fractures Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tibial Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CERAMENT™|BONE VOID FILLER

Device

ceramic bone void filler

Autologous cancellous bone graft

Procedure

autologous cancellous bone graft

Primary outcomes

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

    Time frame: 26 weeks

  2. Global pain VAS score at week 26

    Time frame: 26 weeks

Secondary outcomes

  1. Utilisation of costs of care related resources

    Time frame: 26 weeks

  2. SF-12 PCS and MCS at visit 4

    Time frame: 1 week

  3. Bone healing

    Time frame: 1, 6, 12 and 26 weeks

    Evaluated by X-ray

  4. SF-12 PCS and MCS at visit 5

    Time frame: 6 weeks

  5. SF-12 PCS and MCS at visit 6

    Time frame: 12 weeks

  6. SF-12 PCS and MCS at visit 7

    Time frame: 26 weeks

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures

Acronym: CERTiFy

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Apr 11, 2013
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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