Trial Outcomes & Findings for Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures (NCT NCT00438633)

NCT ID: NCT00438633

Last Updated: 2019-06-21

Results Overview

We measured active forward flexion of the shoulder

• Recruitment status: COMPLETED
• Target enrollment: 63 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-06-21

Participant Flow

Participant milestones

Measure	Early Therapy Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy Subjects who delay therapy for 3 weeks after diagnosis of injury.
Overall Study STARTED	32	31
Overall Study 3-month Follow-up	26	24
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Measure	Early Therapy Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy Subjects who delay therapy for 3 weeks after diagnosis of injury.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	15	17

Baseline Characteristics

Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

Baseline characteristics by cohort

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.	Total n=50 Participants Total of all reporting groups
Age, Continuous	63 Years STANDARD_DEVIATION 13 • n=5 Participants	62 Years STANDARD_DEVIATION 12 • n=7 Participants	63 Years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Injured Hand Dominant	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Injured Hand Non-dominant	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Non- or minimally displaced Yes	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Non- or minimally displaced No	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.

We measured active forward flexion of the shoulder

Outcome measures

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.
Shoulder Flexion	150 Degrees Standard Deviation 26	146 Degrees Standard Deviation 22

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.

Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.

Outcome measures

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.
Shoulder Pain Likert Scores NRS Pain, 3 months	3 units on a scale Standard Deviation 2	3 units on a scale Standard Deviation 1
Shoulder Pain Likert Scores NRS Pain, 6 months	2 units on a scale Standard Deviation 1	2 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.

Outcome measures

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.
External Rotation External Rotation, 3 months	53 Degrees Standard Deviation 30	51 Degrees Standard Deviation 21
External Rotation External Rotation, 6 months	70 Degrees Standard Deviation 17	66 Degrees Standard Deviation 26

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.

Outcome measures

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.
Abduction Abduction, 3 months	115 Degrees Standard Deviation 43	101 Degrees Standard Deviation 41
Abduction Abduction, 6 months	147 Degrees Standard Deviation 27	136 Degrees Standard Deviation 33

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.

Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.

Outcome measures

Measure	Early Therapy n=26 Participants Subjects who begin therapy immediately after diagnosis of injury.	Late Therapy n=24 Participants Subjects who delay therapy for 3 weeks after diagnosis of injury.
Disability of the Hand, Shoulder, and Arm Score DASH, 6 months	18 Units on a scale Standard Deviation 12	14 Units on a scale Standard Deviation 7
Disability of the Hand, Shoulder, and Arm Score DASH, 3 months	33 Units on a scale Standard Deviation 25	24 Units on a scale Standard Deviation 15

Adverse Events

Early Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Late Therapy

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. Neal Chen

Massachusetts General Hospital

Phone: 6177264700

Email: nchen1@partners.org

Results disclosure agreements

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