A Clinical Trial to Evaluate the Safety and Effectiveness of "OLIZ," a Combined Wavelength Photobiomodulation Medical Device, for Surgical Site Pain Relief in Patients Who Have Undergone Total Knee Arthroplasty (TKA) : A Multicenter, Controlled, and Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Change in VAS Pain Score
研究概览
简要总结
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
详细描述
This multicenter, controlled, randomized clinical trial is designed to evaluate the safety and effectiveness of "OLIZ," a medical device that utilizes combined-wavelength photobiomodulation (PBM) therapy, for relieving postoperative pain at the surgical site in patients undergoing total knee arthroplasty (TKA).
Photobiomodulation therapy employs specific wavelengths of light to modulate biological processes at the cellular level, such as reducing inflammation, enhancing microcirculation, and promoting tissue repair. OLIZ delivers dual-wavelength light in the red and near-infrared spectrum, targeting key cellular pathways involved in postoperative pain and recovery.
Participants in the study will be randomly assigned to receive either the active PBM treatment using OILZ or a control intervention. Treatment will begin within 3 days after surgery and continue for a defined period based on the postoperative care protocol. VAS, WOMAC, and recovery metrics will be monitored at multiple time points during the inpatient stay and follow-up period.
The study also aims to assess the safety of repeated PBM exposure in a post-surgical setting by evaluating local and systemic adverse events. Through this trial, investigators seek to generate robust clinical evidence to support the use of OLIZ as a non-pharmacologic modality for pain management and recovery enhancement in TKA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistical analyst responsible for data analysis is masked from randomization assignments and clinical data access until database lock completion
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥19 years and <80 years at the time of consent
- •Radiographic evidence (X-ray) within 24 weeks prior to total knee arthroplasty (TKA) showing Kellgren-Lawrence (KL) grade 4 in the surgical knee
- •Surgical site pain confirmed as a visual analog scale (VAS) score ≥50.0
- •Willingness to refrain from any treatments not permitted by the study protocol, aside from concomitant medications or therapies allowed during the study period
- •Voluntary participation in the clinical trial with written informed consent provided after being fully informed of the study procedures
- •Willingness and ability to comply with the requirements of the clinical trial protocol
排除标准
- •Subjects will be excluded from this clinical trial if they meet any of the following criteria:
- •History of surgery, other than total knee arthroplasty, in the area of the knee joint being evaluated (or scheduled for surgery).*
- •*Includes total/partial knee arthroplasty, knee cartilage surgery, knee ligament reconstruction, autologous chondrocyte implantation, knee fracture surgery, knee synovectomy/loose body removal, patellar reconstruction, patellar realignment, bursectomy, synovectomy, etc.
- •History of using steroids or immunosuppressants at the time of screening, meeting one or more of the following:
- •Immunosuppressants (e.g., cyclosporin A or azathioprine) within 6 weeks.
- •Oral steroids or antidepressants within 4 weeks.
- •Intra-articular injection* into the target knee joint within 12 weeks.
- •*Includes steroids, hyaluronic acid, polynucleotide, PDRN (polydeoxyribonucleotide), etc.
- •Determined to be unable to wear the device due to one or more of the following:
- •Individuals with photosensitive skin.
- •Individuals taking medications that may cause light sensitivity (refer to the precautions of the medication being taken).
- •Individuals with sensitive skin due to an allergic constitution.
- •Individuals with implanted electronic medical devices.
- •Meeting one or more of the following physical examination or laboratory test results at the time of screening:
- •Fever exceeding 37.8°C.
- •PT (INR) or aPTT ≥ 1.5 x ULN (upper limit of normal).
- •Serum creatinine > 1.5 x ULN.
- •AST or ALT ≥ 2.0 x ULN.
- •(Only for those with a history of diabetes) Glycosylated hemoglobin (HbA1c) > 11%.
- •History of one or more of the following medical conditions or diseases confirmed at the time of screening:
- •Secondary osteoarthritis such as rheumatoid arthritis, Paget's disease, or gouty arthritis (however, traumatic osteoarthritis is permitted for enrollment).
- •History of cardiac disease such as myocardial infarction or congestive heart failure.
- •Uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg).
- •History of uncontrolled endocrine abnormalities or diseases (e.g., thyroid disease, parathyroid disease, pituitary disease).
- •Immune system-related diseases (e.g., infectious diseases, systemic lupus erythematosus).
- •History of malignancy within the last 5 years (however, individuals with a history of basal cell or squamous cell skin cancer and non-invasive carcinomas are eligible to participate in the clinical trial only if adequately treated).
- •Pregnant or lactating women.
- •Women of childbearing potential who do not agree to use medically acceptable birth control methods* during the clinical trial period.
- •*Hormonal contraception, intrauterine devices, tubal ligation, double barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, contraceptive sponges), or a single barrier method combined with spermicide.
- •Currently participating in another clinical trial or having participated in another clinical trial within 30 days prior to the screening date.
- •Any other case where, in the investigator's judgment, participation in the clinical trial is deemed inappropriate due to ethical reasons or potential impact on the clinical trial results.
结局指标
主要结局
Change in VAS Pain Score
时间窗: Baseline and 11 weeks post-baseline
Primary efficacy endpoint measuring the change in pain intensity using Visual Analog Scale from baseline to 11 weeks post-baseline. VAS scores range from 0mm (no pain) to 100mm (worst possible pain).
次要结局
- Change in VAS Pain Score at 5 weeks(Baseline and 5 weeks post-baseline)
- Change from baseline in WOMAC total score at Week 5 and Week 11(Baseline, Week 5, and Week 11 post-surgery)
- Change from baseline in knee joint range of motion (ROM) at Week 5 and Week 11(Baseline, Week 5, and Week 11 post-surgery)
- Change from baseline in the cumulative dose of rescue and prescribed analgesic medications at Week 5 and Week 11(Baseline, Week 5, and Week 11 post-surgery)