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

NCT07091773 | Not Yet Recruiting DMC

• 1 other identifier: LT_Knee_Pain-02
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty

Keywords

photobiomodualtion; Total knee arthroplasty; Postoperative pain; Rehabilitation; Pain management

Outcome Measures

Primary Outcomes (1)

• Change in VAS Pain Score

  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).

  Baseline and 11 weeks post-baseline

Secondary Outcomes (4)

• 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

Study Arms (2)

OLIZ Photobiomodulation Treatment

EXPERIMENTAL

Participants will receive photobiomodulation therapy using the OLIZ device, which delivers dual-wavelength light therapy (red and near-infrared spectrum) to the surgical site. Treatment will begin within 3 days post-surgery and continue according to the postoperative care protocol. The OLIZ device targets cellular pathways involved in inflammation reduction, microcirculation enhancement, and tissue repair to manage postoperative pain and promote recovery in total knee arthroplasty patients.

Device: OLIZ Photobiomodulation Device

Standard care control

NO INTERVENTION

Participants will receive standard postoperative care including conventional pain management protocols without photobiomodulation therapy. All other aspects of postoperative care will be identical to the treatment group.

Interventions

OLIZ Photobiomodulation Device DEVICE

OLIZ device utilizes dual-wavelength technology combining specific red (660nm) and near-infrared (850nm) light parameters optimized for post-surgical tissue healing. The device features controlled power density, precise treatment duration protocols, and targeted application to knee arthroplasty surgical sites. Treatment parameters include specific irradiance levels, treatment session duration of 15 minutes, and 3 times of daily application frequency designed.

OLIZ Photobiomodulation Treatment

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LTBIO Co., Ltd.: lead
• Inje University: collaborator
• InjeUniversityIlsanPaikHospital: collaborator
• Gangnam Severance Hospital: collaborator
• National Medical Center, Seoul: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Samsung Medical Center: collaborator
• The Catholic University of Korea Uijeongbu St.Marys Hostpial: collaborator

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Kyung Wook Nha, M.D., Ph.D

  Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Young Kim, master

CONTACT

+82-31-608-1059; summerday@ltbio.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical analyst responsible for data analysis is masked from randomization assignments and clinical data access until database lock completion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: August 20, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share