- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481269
A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device
July 21, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Research Group
Research group uses surface-modified composite coated orthopedic implants
|
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.
|
ACTIVE_COMPARATOR: Controls Group
Controls group uses conventional orthopedic implants
|
conventional orthopedic implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
post-operation infection rate
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF-12 score
Time Frame: 12 months
|
12 months
|
EQ-5D score
Time Frame: 12 months
|
12 months
|
fracture union, malunion, nonunion rate
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2020
Primary Completion (ANTICIPATED)
October 31, 2023
Study Completion (ANTICIPATED)
October 31, 2024
Study Registration Dates
First Submitted
July 19, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (ACTUAL)
July 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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