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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.

NCT06620874 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-10-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Chen Ting-an

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-06-30
Completion
2025-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620874 on ClinicalTrials.gov