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Interscalene Dynamometer Pilot Study

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ClinicalTrials.gov Identifier: NCT01550952
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Total Shoulder Arthroplasty
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
72  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Body Mass Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Normal 1
Overweight 3
Obese 6
1.Primary Outcome
Title Anterior Deltoid Strength
Hide Description Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
One participant declined assessment due to soreness in the shoulder muscle.
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: percent
77
(52 to 119)
2.Primary Outcome
Title Hand Grip Strength
Hide Description Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
One participant declined assessment due to soreness in the shoulder muscle.
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: percent
90
(76 to 99)
3.Secondary Outcome
Title Number of Participants With Reduced Sensation in a Dermatome
Hide Description Pin-prick sensation assessed.
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Dermatomes could not be assessed for one patient due to sedation
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
8
4.Secondary Outcome
Title Numeric Rating Scale (NRS) Pain Scores With Movement
Hide Description NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0.8
(0 to 1.5)
5.Secondary Outcome
Title Total Oral Opioid Intake in 48hrs
Hide Description Opioid Usage
Time Frame 0-48hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mg
52.3  (32.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Shoulder Arthroplasty Patients
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Total Shoulder Arthroplasty Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Shoulder Arthroplasty Patients
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Shoulder Arthroplasty Patients
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jacques YaDeau
Organization: Hospital for Special Surgery
Phone: 2127742224
EMail: yadeauj@hss.edu
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01550952     History of Changes
Other Study ID Numbers: 2011-002
First Submitted: March 1, 2012
First Posted: March 12, 2012
Results First Submitted: January 29, 2016
Results First Posted: March 31, 2016
Last Update Posted: March 31, 2016