Trial Outcomes & Findings for Interscalene Dynamometer Pilot Study (NCT NCT01550952)

NCT ID: NCT01550952

Last Updated: 2016-03-31

Results Overview

Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 days postoperatively
• Results posted on: 2016-03-31

Participant Flow

Participant milestones

Measure	Total Shoulder Arthroplasty Patients
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interscalene Dynamometer Pilot Study

Baseline characteristics by cohort

Measure	Total Shoulder Arthroplasty Patients n=10 Participants
Age, Continuous	72 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Body Mass Index Normal	1 participants n=5 Participants
Body Mass Index Overweight	3 participants n=5 Participants
Body Mass Index Obese	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days postoperatively

Population: One participant declined assessment due to soreness in the shoulder muscle.

Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).

Outcome measures

Measure	Total Shoulder Arthroplasty Patients n=9 Participants
Anterior Deltoid Strength	77 percent Interval 52.0 to 119.0

PRIMARY outcome

Timeframe: 2 days postoperatively

Population: One participant declined assessment due to soreness in the shoulder muscle.

Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).

Outcome measures

Measure	Total Shoulder Arthroplasty Patients n=9 Participants
Hand Grip Strength	90 percent Interval 76.0 to 99.0

SECONDARY outcome

Timeframe: 2 days postoperatively

Population: Dermatomes could not be assessed for one patient due to sedation

Pin-prick sensation assessed.

Outcome measures

Measure	Total Shoulder Arthroplasty Patients n=9 Participants
Number of Participants With Reduced Sensation in a Dermatome	8 participants

SECONDARY outcome

Timeframe: 2 days postoperatively

NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.

Outcome measures

Measure	Total Shoulder Arthroplasty Patients n=10 Participants
Numeric Rating Scale (NRS) Pain Scores With Movement	0.8 units on a scale Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 0-48hrs

Opioid Usage

Outcome measures

Measure	Total Shoulder Arthroplasty Patients n=10 Participants
Total Oral Opioid Intake in 48hrs	52.3 mg Standard Deviation 32.7

Adverse Events

Total Shoulder Arthroplasty Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacques YaDeau

Hospital for Special Surgery

Phone: 2127742224

Email: yadeauj@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place