Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both (RCCT)

Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tears; Rotator Cuff Tendinosis
• Intervention / Treatment: Combination product: Collagen and platelet rich plasma (PRP); Combination product: Collagen; Combination product: Platelet rich plasma (PRP)

Detailed Description

BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes.

AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.

DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-036
      • Sutherland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen and PRP injections; Ultrasound guided injections	Combination product: Collagen and platelet rich plasma (PRP); Ultrasound guided injections
Active Comparator: Collagen injections; Ultrasound guided injections	Combination product: Collagen; Ultrasound guided injections
Active Comparator: PRP injections; Ultrasound guided injections	Combination product: Platelet rich plasma (PRP); Ultrasound guided injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 6 weeks
Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 12 weeks
Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 24 weeks
Width of rotator cuff in ultrasound imaging	Dimensions of cross-section rotator cuff measure in milimeters.	Change from baseline to 24 weeks
Preservation of rotator cuff continuity in ultrasound imaging	Presence / Absence	Change from baseline to 24 weeks
Regenaration of rotator cuff in ultrasound imaging	Presence / Absence	24 weeks
Change in EQ-5D-5L index from baseline to 6 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 6 weeks
Change in EQ-5D-5L index from baseline to 12 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 12 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks	Range: 0 (the best outcome) - 100 (the worst outcome).	Change from baseline to 6 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks	Range: 0 (the best outcome) - 100 (the worst outcome).	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Sutherland Medical Center
• Investigators: Principal Investigator: Piotr Godek, PhD, Sutherland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: SMC2020001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No