Trial Outcomes & Findings for Examining the Effectiveness of a Connective Tissue Matrix Implant in Reducing Post-operative Pain and Narcotic After Outpatient Arthroscopic Shoulder Surgery (NCT NCT04633837)
NCT ID: NCT04633837
Last Updated: 2022-01-06
Results Overview
Utilizing a prospective randomized controlled trial, narcotic use will be measured for 24-hour increments for a total of 7 post-operative days (PODs) then once on POD 14, 21, 28, and 42. Consumption will be measured by the number of tablets ingested and converted to morphine equivalent units and compared between the two treatment groups
TERMINATED
NA
15 participants
Up till 6 weeks
2022-01-06
Participant Flow
1 participant was excluded after enrollment before assignment to a group because the participant did not meet age inclusion/exclusion criteria. 9 participants were enrolled but excluded from the study before assignment to groups because technical errors in data collection were identified before assignment.
Participant milestones
| Measure |
Group 1 Control
Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
|
Group 2: ECM Injectable Graft
Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery
Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Group 1 Control
Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
|
Group 2: ECM Injectable Graft
Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery
Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study.
|
|---|---|---|
|
Overall Study
Participant outcomes data not collected due to technical errors.
|
5
|
0
|
Baseline Characteristics
Examining the Effectiveness of a Connective Tissue Matrix Implant in Reducing Post-operative Pain and Narcotic After Outpatient Arthroscopic Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Group 1 Control
n=5 Participants
Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
|
Group 2: ECM Injectable Graft
Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery
Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up till 6 weeksPopulation: Due to technical errors in the participant-reported data collection system, no outcome measure data was collected from participants.
Utilizing a prospective randomized controlled trial, narcotic use will be measured for 24-hour increments for a total of 7 post-operative days (PODs) then once on POD 14, 21, 28, and 42. Consumption will be measured by the number of tablets ingested and converted to morphine equivalent units and compared between the two treatment groups
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up till 6 weeksPopulation: Due to technical errors in the participant-reported data collection system, no outcome measure data was collected from participants.
Utilizing a prospective randomized controlled trial, post-operative patient-reported VAS pain (on a scale of 0-10) will be collected 1 time per day (every 24 hours) for 7 post-operative days (PODs); then an average score collected on POD 14, POD 21, POD 28, and POD 42. Scores will be averaged and compared between the two treatment groups for the first 7 days, 2 week, 3rd week, 4th week and 6th week postoperatively. A score of zero will indicate no pain and a score of 10 will indicated maximum pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up till 6 monthsPopulation: Due to technical errors in the participant-reported data collection system, no outcome measure data was collected from participants.
To determine if there is a difference in American Shoulder and Elbow scores of patients with rotator cuff tears treated with and without the the ECM implant measured at 2 weeks, 6 weeks, 3 months and 6 months postoperatively. The scoring system is from 0 to a maximum of 100 with the higher scores indicating better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up till 6 monthsPopulation: Due to technical errors in the participant-reported data collection system, no outcome measure data was collected from participants.
Patient reported single assessment numeric evaluation (SANE) score (on a scale of 0 to 100%), measured preoperatively and postoperatively will be assessed for a difference; Scores will be checked at 2 weeks, 6 weeks, 3 months, and 6 months after surgery. A lower number indicates a poorer outcome and a higher number indicates a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up till 6 monthsPopulation: Due to technical errors in the participant-reported data collection system, no outcome measure data was collected from participants.
Patients range of motion including forward flexion, abduction and external rotation will be measured preopertively and postoperatively with a manual goniometer at 6 weeks, 3 months, and 6 months postoperatively.
Outcome measures
Outcome data not reported
Adverse Events
Group 1 Control
Group 2: ECM Injectable Graft
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place