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Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ActiveMatrix® Dosage A
ActiveMatrix® Dosage B
Saline injection
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring musculoskeletal injuries, rotator cuff repair

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study 1-2 tendon full thickness reparable rotator cuff tendon tear(s) Reparable tear defined as: a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension. Full-thickness tear defined as: a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification Have no contraindications or allergies to the treatment administered Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses Able and willing to comply with the post-operative physical therapy and study follow-up schedule Exclusion Criteria: Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery, Prior surgery for bone defects requiring bone implantation in the index shoulder, Steroid injection into the index shoulder within 6 weeks of enrollment. Subscapularis tear greater than 1/3 of tendon involvement requiring repair, Calcific tendonitis in the index shoulder, Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3, Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines, History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2 History of malignant tumor and osseous metastatic disease, History of heterotopic ossification, History of chronic pain disorders (i.e., fibromyalgia), Current substance abuse (drug or alcohol), by the investigator's judgment, For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study, Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study, Currently involved in any injury litigation or workers compensation claims, has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ActiveMatrix® Dosage A

ActiveMatrix® Dosage B

Saline Injection

Arm Description

Outcomes

Primary Outcome Measures

Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity

Secondary Outcome Measures

Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides
Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes.
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability.

Full Information

First Posted
May 30, 2023
Last Updated
May 30, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Skye Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT05894265
Brief Title
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
Official Title
Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 5, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Skye Biologics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
musculoskeletal injuries, rotator cuff repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ActiveMatrix® Dosage A
Arm Type
Experimental
Arm Title
ActiveMatrix® Dosage B
Arm Type
Experimental
Arm Title
Saline Injection
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
ActiveMatrix® Dosage A
Other Intervention Name(s)
Human Placental Connective Tissue-Derived Allograft
Intervention Description
This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
Intervention Type
Other
Intervention Name(s)
ActiveMatrix® Dosage B
Other Intervention Name(s)
Human Placental Connective Tissue-Derived Allograft
Intervention Description
Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
Intervention Type
Procedure
Intervention Name(s)
Saline injection
Intervention Description
Group 3 will receive saline injection
Primary Outcome Measure Information:
Title
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Description
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity
Time Frame
6 months post surgery , 12 months post surgery
Secondary Outcome Measure Information:
Title
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
Description
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides
Time Frame
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Title
Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Description
The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes.
Time Frame
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Title
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Description
VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity
Time Frame
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Title
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
Description
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability.
Time Frame
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study 1-2 tendon full thickness reparable rotator cuff tendon tear(s) Reparable tear defined as: a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension. Full-thickness tear defined as: a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification Have no contraindications or allergies to the treatment administered Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses Able and willing to comply with the post-operative physical therapy and study follow-up schedule Exclusion Criteria: Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery, Prior surgery for bone defects requiring bone implantation in the index shoulder, Steroid injection into the index shoulder within 6 weeks of enrollment. Subscapularis tear greater than 1/3 of tendon involvement requiring repair, Calcific tendonitis in the index shoulder, Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3, Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines, History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2 History of malignant tumor and osseous metastatic disease, History of heterotopic ossification, History of chronic pain disorders (i.e., fibromyalgia), Current substance abuse (drug or alcohol), by the investigator's judgment, For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study, Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study, Currently involved in any injury litigation or workers compensation claims, has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric F Berkman, MD
Phone
713-314-4112
Email
Eric.F.Berkman@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Layla Haidar
Phone
713-486-5529
Email
Layla.Haidar@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric F Berkman, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric F Berkman, MD
Phone
713-314-4112
Email
Eric.F.Berkman@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Layla Haidar
Phone
713-486-5529
Email
Layla.Haidar@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

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