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A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device

Primary Purpose

Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surface-modified composite coated orthopedic implants
conventional orthopedic implants
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Limb fracture group criteria

    1. Age 18-75 years old, no gender limit
    2. The preoperative diagnosis is clearly Anderson-Gustilo type III open fracture patient
    3. Postoperative diagnosis stage is IIIA or IIIB patients with open fracture
    4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent
  • Joint replacement group criteria

    1. Age 40-75 years old, no gender limit
    2. The patient is clearly diagnosed as degenerative osteoarthritis before the operation, and the postoperative diagnosis is the same as before the operation
    3. Patients can tolerate implantation operation
    4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent
  • Spine patients group criteria

    1. Age 40-75 years old, no gender limit
    2. Before surgery, it is clearly diagnosed as degenerative spine disease and spine requiring intervertebral fusion
    3. Patients can tolerate implantation operation
    4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent

Exclusion Criteria:

  • 1. The subject is pregnant or breastfeeding, or a woman of childbearing age does not agree to take effective contraceptive measures during the period 2. Closed fractures or pathological fractures (such as primary or metastatic tumors) 3. Patients with symptoms of compartment syndrome 4. According to Gustilo-Anderson classification of open fractures into type I and type II patients 5. Multiple injuries, determined by the researcher to be unsuitable for research 6. The patient is allergic to metal plants 7. Combined with certain medical diseases, it is determined by the investigator to be unsuitable for the study, for example metabolic bone disease, sequelae of polio, poor bone quality, poor bone healing 8. The patient has participated in other clinical trials in the past 3 months 9. The patient has contraindications to anesthesia and surgery 10. Patients with congenital malformations, local or systemic infections, skin diseases 11. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid, long-term use of sedative and hypnotics (using more than 3 consecutive months) or non-steroidal anti-inflammatory drugs (continuous use for more than 3 months) 12. The patient's compliance is poor, and the research staff determines that it cannot be completed according to the research plan. No consent for voluntary participation in clinical research was provided.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Research Group

    Controls Group

    Arm Description

    Research group uses surface-modified composite coated orthopedic implants

    Controls group uses conventional orthopedic implants

    Outcomes

    Primary Outcome Measures

    post-operation infection rate

    Secondary Outcome Measures

    SF-12 score
    EQ-5D score
    fracture union, malunion, nonunion rate

    Full Information

    First Posted
    July 19, 2020
    Last Updated
    July 21, 2020
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04481269
    Brief Title
    A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device
    Official Title
    A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a prospective, randomized, controlled, double-arm, non-inferiority study that will be carried out in China. It aims to compare two implant systems (the research group uses surface-modified composite coated orthopedic implants, and controls group using conventional orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the distribution of patients in the treatment group and the control group is consistent. Patients will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main indicator for evaluation is the postoperative infection rate, and the secondary indicators include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing, malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue complications Symptom incidence rate. The follow-up data will be used to determine the main safety and effectiveness of the new surface modified composite coated orthopedic implant system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Research Group
    Arm Type
    Experimental
    Arm Description
    Research group uses surface-modified composite coated orthopedic implants
    Arm Title
    Controls Group
    Arm Type
    Active Comparator
    Arm Description
    Controls group uses conventional orthopedic implants
    Intervention Type
    Device
    Intervention Name(s)
    Surface-modified composite coated orthopedic implants
    Intervention Description
    The surface-modified composite coated orthopedic implants have the capacity of high binding strength, high tissue-inducing activity and intelligent bacteria-resistance. The implant devices are expected to be used in the prevention and treatment of plant-related infections in orthopedic surgeries.
    Intervention Type
    Device
    Intervention Name(s)
    conventional orthopedic implants
    Intervention Description
    conventional orthopedic implants
    Primary Outcome Measure Information:
    Title
    post-operation infection rate
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    SF-12 score
    Time Frame
    12 months
    Title
    EQ-5D score
    Time Frame
    12 months
    Title
    fracture union, malunion, nonunion rate
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Limb fracture group criteria Age 18-75 years old, no gender limit The preoperative diagnosis is clearly Anderson-Gustilo type III open fracture patient Postoperative diagnosis stage is IIIA or IIIB patients with open fracture The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent Joint replacement group criteria Age 40-75 years old, no gender limit The patient is clearly diagnosed as degenerative osteoarthritis before the operation, and the postoperative diagnosis is the same as before the operation Patients can tolerate implantation operation The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent Spine patients group criteria Age 40-75 years old, no gender limit Before surgery, it is clearly diagnosed as degenerative spine disease and spine requiring intervertebral fusion Patients can tolerate implantation operation The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent Exclusion Criteria: 1. The subject is pregnant or breastfeeding, or a woman of childbearing age does not agree to take effective contraceptive measures during the period 2. Closed fractures or pathological fractures (such as primary or metastatic tumors) 3. Patients with symptoms of compartment syndrome 4. According to Gustilo-Anderson classification of open fractures into type I and type II patients 5. Multiple injuries, determined by the researcher to be unsuitable for research 6. The patient is allergic to metal plants 7. Combined with certain medical diseases, it is determined by the investigator to be unsuitable for the study, for example metabolic bone disease, sequelae of polio, poor bone quality, poor bone healing 8. The patient has participated in other clinical trials in the past 3 months 9. The patient has contraindications to anesthesia and surgery 10. Patients with congenital malformations, local or systemic infections, skin diseases 11. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid, long-term use of sedative and hypnotics (using more than 3 consecutive months) or non-steroidal anti-inflammatory drugs (continuous use for more than 3 months) 12. The patient's compliance is poor, and the research staff determines that it cannot be completed according to the research plan. No consent for voluntary participation in clinical research was provided.

    12. IPD Sharing Statement

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    A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device

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