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

NCT ID: NCT04481269

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-10-31

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.

Conditions

Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Research Group

Research group uses surface-modified composite coated orthopedic implants

Group Type: EXPERIMENTAL

Surface-modified composite coated orthopedic implants

Intervention Type: DEVICE

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.

Controls Group

Controls group uses conventional orthopedic implants

Group Type: ACTIVE_COMPARATOR

conventional orthopedic implants

Intervention Type: DEVICE

conventional orthopedic implants

Interventions

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.

Intervention Type: DEVICE

conventional orthopedic implants

conventional orthopedic implants

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

20200718

Identifier Type: -

Identifier Source: org_study_id