NCT05971004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 17, 2023

Last Update Submit

July 30, 2023

Conditions

Collateral Ligament Injury of Stifle Joint

Keywords

Collateral Ligament PainKnee PainKnee InstabilitySports TraumaCollagen Peptide InjectionsLigament Healing

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • VAS (Visual Analogue Pain)

    Baseline, 3 months, 6 months

  • Ultrasound

    Baseline, 3 months, 6 months

  • Likert

    Baseline, 6 months

  • WOMAC

    Baseline, 3 months

Study Arms (2)

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).

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.

Drug: Depo medrol

Interventions

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

Collagen Peptide Group
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.

Cortison Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiss'You

Domagnano, RSM, 47895, San Marino

Location

MeSH Terms

Interventions

Methylprednisolone Acetate

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 2, 2023

Study Start

April 13, 2022

Primary Completion

October 10, 2022

Study Completion

April 4, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)