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
About this trial
This is an interventional treatment trial for Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases
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.
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
NCT ID
NCT04481269
First Posted
July 19, 2020
Last Updated
July 21, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Learn more about this trial
A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device
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