MORA Cure for Knee Osteoarthritis With Anterior Knee Pain

A Prospective, Multicenter, Single-Arm, Pilot Study to Evaluate the Clinical Outcomes and Safety of the Digital Therapeutic MORA Cure in Patients With Knee Osteoarthritis Accompanied by Anterior Knee Pain: 8-week

This prospective, multicenter, single-arm, sponsor-initiated pilot study will evaluate the clinical course and safety of MORA Cure in adults older than 50 years with knee osteoarthritis accompanied by anterior knee pain. Participants will use MORA Cure for 8 weeks. MORA Cure provides personalized rehabilitation exercises and cognitive behavioral therapy-based content through a patient mobile application supported by a clinician web portal. Clinical outcomes will be assessed at baseline, Week 4, and Week 8. The planned enrollment is 44 participants at two sites in the Republic of Korea.

The study includes a screening visit conducted within 4 weeks before baseline. The screening and baseline visits may occur on the same day; therefore, each participant will complete 3 or 4 outpatient visits. At baseline, the investigator will prescribe MORA Cure and assist with installation and initiation of the patient mobile application. Participants will use MORA Cure for 8 weeks, perform personalized rehabilitation exercises at least 3 times per week for approximately 30 minutes per session, and complete cognitive behavioral therapy content according to weekly sessions.

Assessments include usual and worst overall knee pain, usual and worst anterior knee pain using a 0-100 visual analog scale, the Knee injury and Osteoarthritis Outcome Score, the Anterior Knee Pain Scale (Kujala), the 30-second Sit-to-Stand Test, EQ-5D-5L and EQ-VAS, the Patient Health Questionnaire-9, the Pain Catastrophizing Scale, participant satisfaction, the System Usability Scale, and adverse events. Body weight and exercise performed outside MORA Cure are collected as exploratory factors.

This is a single-arm exploratory pilot study without a comparator group. Accordingly, observed changes cannot distinguish the effect of MORA Cure from natural improvement or other time-related factors. The Week 8 change in usual overall knee pain is designated as the primary outcome for registry organization only and will be interpreted as a principal exploratory outcome, not as confirmatory evidence of efficacy.

Inclusion Criteria:

1. Adults older than 50 years.
2. Kellgren-Lawrence grade 1 or higher on weight-bearing plain radiographs of the study knee.
3. Osteoarthritis-related pain in the study knee for at least 3 months.
4. Anterior knee pain in the study knee involving the peripatellar, anterior patellar, or retropatellar region, with clear provocation or worsening of anterior knee pain during at least one patellofemoral joint-loading activity: stair ascent or descent, squatting, or rising from a chair.
5. If medial, lateral, or posterior knee pain is also present, the participant is able to distinguish and separately report anterior knee pain.
6. Voluntary written informed consent before study participation.

Exclusion Criteria:

1. Acute injury of the study knee within the previous 3 months, including fracture, ligament tear, or meniscal tear requiring surgical treatment or immobilization.
2. Injection therapy to the study knee within the previous 3 months.
3. Current use of opioid analgesics for pain control.
4. Does not own a smartphone or is unable to use the mobile application.
5. Current participation in another clinical trial or planned participation in another clinical trial during this study.
6. Diagnosed active inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or reactive arthritis.
7. Acute attack of gout or pseudogout in the study knee within the previous 3 months.
8. Previous total knee arthroplasty, corrective osteotomy, or other major surgery affecting knee alignment or joint structure in the study knee.
9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.