Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04492748
Other study ID # SMC2020001
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2020
Est. completion date September 30, 2021

Study information

Verified date March 2021
Source Sutherland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Combination Product:
Collagen and platelet rich plasma (PRP)
Ultrasound guided injections
Collagen
Ultrasound guided injections
Platelet rich plasma (PRP)
Ultrasound guided injections

Locations

Country Name City State
Poland Sutherland Medical Center Warsaw Mazowieckie

Sponsors (1)

Lead Sponsor Collaborator
Sutherland Medical Center

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Pain according to Numeric Rating Scale (NRS) 0 (no pain) - 10 points (the worst possible pain) Change from baseline to 6 weeks
Secondary Pain according to Numeric Rating Scale (NRS) 0 (no pain) - 10 points (the worst possible pain) Change from baseline to 12 weeks
Secondary Pain according to Numeric Rating Scale (NRS) 0 (no pain) - 10 points (the worst possible pain) Change from baseline to 24 weeks
Secondary Width of rotator cuff in ultrasound imaging Dimensions of cross-section rotator cuff measure in milimeters. Change from baseline to 24 weeks
Secondary Preservation of rotator cuff continuity in ultrasound imaging Presence / Absence Change from baseline to 24 weeks
Secondary Regenaration of rotator cuff in ultrasound imaging Presence / Absence 24 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04974242 - Physiotherapy for Patients Awaiting Rotator Cuff Repair N/A
Recruiting NCT06055478 - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair N/A
Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Not yet recruiting NCT06032416 - DenCT Shoulder Bone Quality Evaluation N/A
Not yet recruiting NCT04047745 - Post-operative Exparel Study Following Rotator Cuff Repair N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A