NCT04492748

Brief Summary

The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

July 20, 2020

Last Update Submit

March 10, 2021

Conditions

Rotator Cuff TendinosisRotator Cuff Tears

Outcome Measures

Primary Outcomes (2)

  • Change in EQ-5D-5L index from baseline to 24 week

    EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.

    Change from baseline to 24 weeks

  • QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks

    Range: 0 (the best outcome) - 100 (the worst outcome).

    Change from baseline to 24 weeks

Secondary Outcomes (10)

  • Pain according to Numeric Rating Scale (NRS)

    Change from baseline to 6 weeks

  • Pain according to Numeric Rating Scale (NRS)

    Change from baseline to 12 weeks

  • Pain according to Numeric Rating Scale (NRS)

    Change from baseline to 24 weeks

  • Width of rotator cuff in ultrasound imaging

    Change from baseline to 24 weeks

  • Preservation of rotator cuff continuity in ultrasound imaging

    Change from baseline to 24 weeks

  • +5 more secondary outcomes

Study Arms (3)

Collagen and PRP injections

EXPERIMENTAL

Ultrasound guided injections

Combination Product: Collagen and platelet rich plasma (PRP)

Collagen injections

ACTIVE COMPARATOR

Ultrasound guided injections

Combination Product: Collagen

PRP injections

ACTIVE COMPARATOR

Ultrasound guided injections

Combination Product: Platelet rich plasma (PRP)

Interventions

Collagen and platelet rich plasma (PRP)COMBINATION_PRODUCT

Ultrasound guided injections

Collagen and PRP injections
CollagenCOMBINATION_PRODUCT

Ultrasound guided injections

Collagen injections
Platelet rich plasma (PRP)COMBINATION_PRODUCT

Ultrasound guided injections

PRP injections

Eligibility Criteria

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

You may qualify if:

  • clinical signs and symptoms of rotator cuff pathology
  • an adult person consenting to injections
  • partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA)
  • no traumatic event
  • no injections or any other local treatment in previous 1 month

You may not qualify if:

  • full thickness rotator cuff injury
  • acute, traumatic injuries requiring surgical treatment
  • coexisting injuries of the shoulder joint requiring other intervention
  • severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA)
  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutherland Medical Center

Warsaw, Masovian Voivodeship, 04-036, Poland

Location

Related Publications (1)

  • Godek P, Szczepanowska-Wolowiec B, Golicki D. Collagen and platelet-rich plasma in partial-thickness rotator cuff injuries. Friends or only indifferent neighbours? Randomised controlled trial. BMC Musculoskelet Disord. 2022 Dec 20;23(1):1109. doi: 10.1186/s12891-022-06089-9.

    PMID: 36536333DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Collagen

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Piotr Godek, PhD

    Sutherland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 30, 2020

Study Start

July 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)