NCT06620874

Comparison of the Efficacy of Ultrasound-Guided Injections of Saline, High-Concentration Dextrose, and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis: A Randomized Double-Blind Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Chen Ting-an · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. This prospective, double-blind, randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department. The main questions it aims to answer are: 1. Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline? 2. What side effects do participants experience with these treatments? Participants will be randomly divided into three groups: STABHA, high-concentration glucose water, and saline. In addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. All participants will also undergo a 4-week physical therapy program. Participants will: 1. Receive two ultrasound-guided injections over two weeks. 2. Undergo 4 weeks of physical therapy. 3. Return for follow-up assessments at 1 and 3 months, including the WOMAC osteoarthritis index, pain score, KOOS knee outcome score, knee range of motion, and knee ultrasound examination.

Conditions

• Medial Collateral Ligament Lesions
• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	STABHA Injection	Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval
OTHER	High-Concentration Glucose Water Injection	Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval
OTHER	Saline Injection	Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2024-10-01
• Last updated: 2024-10-01