Safety and Efficacy of Newly Developed Knee Prosthesis for Knee Arthroplasty

NCT03184129 | Unknown DMC

• 1 other identifier: TaiheH_001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To verify and assess the safety and efficacy of newly developed knee prosthesis (Wuhan Yijiabao Biomaterial Co., Ltd.) in total knee arthroplasty.

Conditions

Knee Disease

Outcome Measures

Primary Outcomes (1)

• Hospital for Special Surgery Knee Scores

  To evaluate the recovery of knee function.That is the percentage of the number of patients with excellent and good HSS scores after surgery in each group. HSS scores: total score is 100. Excellent: 85-100; good: 70-84; average: 60-69; poor: less than 59.

  at postoperative 12 months (±15 days)

Secondary Outcomes (1)

• X-ray

  at postoperative 12 months (±15 days)

Study Arms (2)

trial group

EXPERIMENTAL

Patients with knee disease who will undergo knee arthroplasty will be randomized into trial group. The patients from the trial group will receive knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co., Ltd., Wuhan, China (newly developed).

Device: trial group

control group

EXPERIMENTAL

Patients with knee disease who will undergo knee arthroplasty will be randomized into control group. The patients from the control group will receive knee arthroplasty with knee prostheses purchased from Beijing AKEC Medical Co., Ltd., Beijing, China (approved by China Food and Drug Administration).

Device: control group

Interventions

trial group DEVICE

Patients with knee disease who will undergo knee arthroplasty will be randomized into trial group. The patients from the trial group will receive newly developed knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co., Ltd..

Also known as: newly developed knee prosthesis

trial group

control group DEVICE

Patients with knee disease who will undergo knee arthroplasty will be randomized into control group. The patients from the control group will receive knee arthroplasty with knee prostheses purchased from Beijing AKEC Medical Co., Ltd., Beijing, China (approved by China Food and Drug Administration).

Also known as: knee prosthesis approved by CFDA

control group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one knee disease: Primary or secondary knee osteoarthritis, traumatic arthritis, rheumatoid arthritis or ankylosing spondylitis and other systemic diseases involving the knee, degenerative arthritis, tumor resection of the knee, varus or valgus correction of the knee and fracture of the knee joint
• At the age of at least 35 years old, irrespective of sex
• Bone is mature; that is, knee X-ray shows epiphyseal closure
• First total knee arthroplasty
• Willing and able to sign informed consent

You may not qualify if:

• Neuromuscular dysfunction (such as paralysis, rhabdomyolysis, or abductor weakness) can lead to instability or gait abnormalities in the knee after surgery
• Mentally incapable or unable to understand the requirements for participation in research
• Expected to be incompatible (such as alcohol, drug addicts, drug abusers; unwilling to accept a 12-month study plan; the patient's expected value is unrealistic or the patient has a clear emotional problem)
• Allergic to one or more implants
• An active infection lesion in the knee joint or other parts of the body
• Severe osteoporosis, bone defect, metabolic bone disease and radioactive bone disease around the knee joint
• Frail or unable to tolerate surgery because of other diseases of the body, or a life expectancy of less than 2 years
• A pregnant or lactating woman or woman expecting to have children
• The combination of other diseases restricts its participation in the study; failure to follow up or influence the scientific nature and integrity of the study (for example, other lower joint (ankle) disorders cause severe functional impairment and influence assessment; other primary joints (knee and hip) have been implanted with joint prostheses)
• Participation in other clinical trials of drug, biological agents or instruments, and have not reach the research time limit

Sponsors & Collaborators

• Taihe Hospital: lead

Study Sites (1)

Taihe Hospital

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Taifang Gong, Ph.D

  Taihe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: February 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

CN (1)