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Completed

NCT Number: NCT02056834

chronOS Inject in Proximal Tibial Fractures

The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.

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Key information

Conditions

Closed Proximal Tibial Fracture Schatzker I - VI Closed Proximal Tibial Fracture AO-OTA 41 Closed Proximal Tibial Fracture AO-OTA 42

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Hospital, Daegu, South Korea

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About this study

The primary objective of this study was to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures. Secondary objectives were to assess the surgeon's satisfaction in using chronOS Inject and patient satisfaction post surgery.

The study was planned to be a multi-center, prospective, observational study. Patients with proximal tibial fractures of type Schatzker I - VI, AO-Müller-Orthopaedic Trauma Association (AO-OTA) 41, AO-OTA 42 with bone defect were assessed for eligibility to enter the study. Patients eligible for the study were followed over time to twelve months after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
  • Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
  • Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study

Exclusion criteria

  • Open fractures with severe soft tissue damage
  • Proximal tibial fractures with tumor or osteomyelitis
  • Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
  • Osteopenia or Osteoporosis: if dual energy x-ray absorptiometry (DEXA) is required, exclusion will be defined as a DEXA bone density measured T score <=-1.0
  • Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
  • Morbid obesity defined as a body mass index >40 kg/m2 or weight more than 50 kg over ideal body weight
  • Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years
  • Known or documented history of communicable disease, including AIDS and HIV
  • Active Hepatitis (receiving medical treatment within two years)
  • Active systemic or local infection
  • Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
  • Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
  • Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for >1 month within last 12 months
  • Pregnant or planning to become pregnant during study period
  • Involved in study of another investigational product that may affect outcome
  • History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales
  • Patients who are incarcerated

Treatment and study plan

chronOS Inject

Device

chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

Primary outcomes

  1. Fracture Union

    Time frame: 12 months

    Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays

  2. Articular Subsidence

    Time frame: 12 months

    Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators

  3. Mean Time to Union

    Time frame: 12 months

    Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function

Secondary outcomes

  1. Absorption Rate of Calcium Phosphate Cement

    Time frame: 12 months

    Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.

  2. Patients Who Reached Full Weight Bearing

    Time frame: 12 months

  3. Total Range of Motion

    Time frame: 12 months

  4. Anatomical Gradings Assessed Radiographically

    Time frame: 12 months

    The following was assessed:

    • depression of knee joint: presence or absence
    • condylar widening (enlargement of the knee joint): presence or absence
    • angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence

  5. Patient's Satisfaction

    Time frame: 12 months

    Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.

  6. Surgeon's Satisfaction With the Product

    Time frame: Post-surgery

    Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.

  7. Extension Ability and Stability

    Time frame: 12 months

    The following was assessed:

    • extension ability of the knee
    • stability of the knee in extension

  8. Peri-operative Complications

    Time frame: 12 months

  9. SF-12 Short Form Health Survey Physical Composite Score (PCS)

    Time frame: 12 months

    The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.

  10. SF-12 Short Form Health Survey Mental Composite Score (MCS)

    Time frame: 12 months

    The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.

  11. VAS Leg Pain Intensity

    Time frame: 12 months

    The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.

  12. VAS Leg Pain Frequency

    Time frame: 12 months

    The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.

  13. Lysholm Knee Scale

    Time frame: 12 months

    The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.

Sponsors and collaborators

Lead sponsor

Synthes GmbH

Industry

Registry information

Official study title

Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2014
Registry last updated
Mar 3, 2025

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.