An interventional study of STABHA Injection and High-Concentration Glucose Water Injection in Medial Collateral Ligament Lesions and Knee Osteoarthritis, sponsored by Chen Ting-an. Not yet recruiting. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Chen Ting-an · Not applicable, Interventional, and Treatment
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:
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:
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 51 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Chen Ting-an as lead sponsor.
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The patients should fulfill the following criteria:
Exclusion Criteria:
The exclusion criteria are:
Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval.
Biological: STABHA 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: High-Concentration Glucose Water Injection
Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval.
Other: Saline Injection
Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval
Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval
Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval
Pain Reduction Using WOMAC Osteoarthritis Index
The primary outcome will assess the change in pain scores using the WOMAC Osteoarthritis Index at baseline, 1 month, and 3 months after the treatment intervention
Time frame: Baseline, 1 month, and 3 months post-intervention
Knee Range of Motion
The change in knee range of motion will be measured using a goniometer at baseline, 1 month, and 3 months after intervention
Time frame: Baseline, 1 month, and 3 months post-intervention
KOOS Knee Outcome Score
The outcome will assess the change in KOOS Knee Outcome Score at baseline, 1 month, and 3 months after the treatment intervention
Time frame: Baseline, 1 month, and 3 months post-intervention
Change in Medial Collateral Ligament (MCL) Characteristics in Knee Ultrasound Examination
The outcome will assess changes in the characteristics of the medial collateral ligament (MCL) of the knee using ultrasound examination. Measurements will include MCL thickness, echogenicity, and presence of any structural abnormalities (e.g., calcifications, tears). Ultrasound evaluations will be performed at baseline, 1 month, and 3 months after the intervention to determine the treatment effects on MCL condition.
Time frame: Baseline, 1 month, and 3 months post-intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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