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chronOS Inject in Proximal Tibial Fractures

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ClinicalTrials.gov Identifier: NCT02056834
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment
Closed Proximal Tibial Fracture Schatzker I - VI Closed Proximal Tibial Fracture AO-OTA 41 Closed Proximal Tibial Fracture AO-OTA 42 Device: chronOS Inject

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : March 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
chronOS Inject
Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Device: chronOS Inject
chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with proximal tibial fractures of type Schatzter I - VI, AO-OTA 41, AO-OTA 42 with bone defect are assessed for eligibility to enter the study. A computerized tomography is performed if necessary to confirm the fracture type and the amount of bone defect. Patients eligible for the study are followed over time to 12 months after surgery.

A total of 30 patients who meet the inclusion/exclusion criteria are enrolled in the study, which is conducted at Kyungpook National University Hospital and Hanyang University Guri Hospital in the Republic of Korea.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056834


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Hanyang University Guri Hospital
Guri, Korea, Republic of, 471-701
Sponsors and Collaborators
Synthes GmbH
Investigators
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Principal Investigator: Chang-Wug Oh, MD Kyungpook National University Hospital
Principal Investigator: Kichul Park, MD Hanyang University
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Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT02056834    
Other Study ID Numbers: STU-BIO-T-XX-004-04
First Posted: February 6, 2014    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries