Collateral Ligament Injury of Stifle JointNCT05971004
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain
A study testing Arthrys (Collagen Peptide solution) and Depo medrol in people with Collateral Ligament Injury of Stifle Joint, run by Tiss'You srl at 1 site in San Marino.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Collateral Ligament Injury of Stifle Joint
- What is being tested?
- Arthrys (Collagen Peptide solution) and Depo medrol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSan Marino
- Study dates
- 13 Apr 2022to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
San Marino1 site
Tiss'You
Domagnano, RSM, 47895
About this study
Official title: Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial
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.
- Being tested
- Arthrys (Collagen Peptide solution), Depo medrol
- Keywords
- Collateral Ligament Pain, Knee Pain, Knee Instability, Sports Trauma, Collagen Peptide Injections, Ligament Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrys (Collagen Peptide solution)Device
one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point
Depo medrolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Collagen Peptide Group | Experimental | The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle). Receives: Device: Arthrys (Collagen Peptide solution) |
| Cortison Group | Active comparator | The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and 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. Receives: Drug: Depo medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
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.
Measured: 6 months
Secondary outcomes (4)
VAS (Visual Analogue Pain)
Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain)
Measured: Baseline, 3 months, 6 months
Ultrasound
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.
Measured: Baseline, 3 months, 6 months
Likert
Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction)
Measured: Baseline, 6 months
WOMAC
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start13 Apr 2022
- Primary completion10 Oct 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collateral Ligament Injury of Stifle JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiss'You srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prof. Binh Luu Thi, Tiss'You srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971004
- Sponsor's protocol ID
- Collagen Peptide Ligament
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05971004
- Acronym / sponsor ID
- Collagen Peptide Ligament
- Keywords
- Collateral Ligament Pain, Knee Pain, Knee Instability, Sports Trauma, Collagen Peptide Injections, Ligament Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tiss'You srlIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen Peptide Group | Experimental | Device: Arthrys (Collagen Peptide solution)The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle). |
| Cortison Group | Active comparator | Drug: Depo medrolThe Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrys (Collagen Peptide solution)one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point | Device | Collagen Peptide Group |
| Depo medrolone 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. | Drug | Cortison Group |
Primary outcome
WOMAC
Time frame: 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.
4 secondary outcomes
VAS (Visual Analogue Pain)
Time frame: Baseline, 3 months, 6 months
Ultrasound
Time frame: Baseline, 3 months, 6 months
Likert
Time frame: Baseline, 6 months
WOMAC
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrys (Collagen Peptide solution) and Depo medrol in people with Collateral Ligament Injury of Stifle Joint, run by Tiss'You srl at 1 site in San Marino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in San Marino. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.