Collateral Ligament Injury of Stifle Joint
Conditions
Keywords
Collateral Ligament Pain, Knee Pain, Knee Instability, Sports Trauma, Collagen Peptide Injections, Ligament Healing
Brief summary
Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National Hospital, the study investigates a new approach to treating persistent collateral ligament pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen peptide injections, a treatment that addresses pain and inflammation in ways previous methods have not. The study involves a randomized controlled trial with 62 patients, all diagnosed with inflammation in the collateral ligament site. The patients are split into two groups: one receiving collagen injections alongside oral painkillers and the other receiving depo-medrol injections with oral painkillers.
Interventions
DEVICEArthrys (Collagen Peptide solution)
one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point
DRUGDepo medrol
one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.
Sponsors
Tiss'You srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age above 18 years, * lateral knee pain with a duration of 3 months or longer, * ultrasound evidence of inflammation of the femoral condyle attachment point, * agreement to participate in the study
Exclusion criteria
* trauma, * infection, * dermatitis at the site of the inflammation, * damage to surrounding knee structures, * history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis), * local corticosteroid injection within 3 months before participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | 6 months | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Pain) | Baseline, 3 months, 6 months | Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain) |
| Ultrasound | Baseline, 3 months, 6 months | Ultrasound evaluation for hypoechoic (signal reduction), normal, and hyperechoic (signal amplification) ligaments. Hypoechoic signal suggests damage or degeneration of the ligament; normal signal suggests healthy ligament tissue; hyperechoic signal suggests calcification, scar, or inflammation. |
| Likert | Baseline, 6 months | Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction) |
| WOMAC | Baseline, 3 months | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. |
Countries
San Marino
Outcome results
None listed