Trial Outcomes & Findings for Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty (NCT NCT02052466)

NCT ID: NCT02052466

Last Updated: 2017-05-09

Results Overview

At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.

• Recruitment status: COMPLETED
• Target enrollment: 32 participants
• Primary outcome timeframe: At least 24 months after reverse TSA
• Results posted on: 2017-05-09

Participant Flow

Participant milestones

Measure	Reverse TSA Patients Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Reverse TSA Patients Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Overall Study Withdrawal by Subject	1
Overall Study Acromial fracture	1

Baseline Characteristics

Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

Baseline characteristics by cohort

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Age, Continuous	71.08 years STANDARD_DEVIATION 6.06 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: At least 24 months after reverse TSA

Population: Patients who had video motion analysis of their range of motion at minimum 2 year follow-up

At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.

Outcome measures

Measure	Reverse TSA Patients n=29 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Actual Versus Predicted Scapular Notching	96.6 percentage of accurate predictions

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better.

The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score.

The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as "not satisfied" and 10 as "very satisfied".

The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved.

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)	78.4 Scores on the Penn Shoulder Score scale Standard Deviation 17.2

SECONDARY outcome

Timeframe: At least 24 months after TSA

Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Shoulder Strength - Flexion	10.2 pounds Standard Deviation 3.8

SECONDARY outcome

Timeframe: At least 24 months after TSA

Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Shoulder Strength - Abduction	11.3 pounds Standard Deviation 3.8

SECONDARY outcome

Timeframe: At least 24 months after TSA

Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Shoulder Strength - Internal Rotation	9.7 pounds Standard Deviation 4.0

SECONDARY outcome

Timeframe: At least 24 months after TSA

Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Shoulder Strength - External Rotation	7.5 pounds Standard Deviation 3.2

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

Flexion

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Active Shoulder Range of Motion - Flexion	134.5 Degrees Standard Deviation 27.3

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

Abduction

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Active Shoulder Range of Motion - Abduction	120.5 Degrees Standard Deviation 26.1

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

External rotation

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Active Shoulder Range of Motion - External Rotation	26.8 Degrees Standard Deviation 19

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

Flexion

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Passive Shoulder Range of Motion - Flexion	141.7 Degrees Standard Deviation 24.0

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

Abduction

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Passive Shoulder Range of Motion - Abduction	128.0 Degrees Standard Deviation 25.1

SECONDARY outcome

Timeframe: At least 24 months after reverse TSA

External rotation

Outcome measures

Measure	Reverse TSA Patients n=30 Participants Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Passive Shoulder Range of Motion - External Rotation	43 Degrees Standard Deviation 16.2

Adverse Events

Reverse TSA Patients

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reverse TSA Patients n=30 participants at risk Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
Musculoskeletal and connective tissue disorders Hip fracture due to fall	6.7% 2/30 • Number of events 2 • Minimum 2 years after surgery
Musculoskeletal and connective tissue disorders Fracture of acromion	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Cardiac disorders A-fib with rapid ventricular response	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Cardiac disorders Transient ischemic attack	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Renal and urinary disorders Bladder tumor	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Infections and infestations Pneumonia	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Infections and infestations Cellulitis	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Vascular disorders External artery, common femoral, and profunda endarterectomy	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery
Metabolism and nutrition disorders Thiamine deficiency	3.3% 1/30 • Number of events 1 • Minimum 2 years after surgery

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Ricchetti

Cleveland Clinic Foundation

Phone: 2164456915

Email: ricchee@ccf.org

Results disclosure agreements

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