Trial Outcomes & Findings for Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures (NCT NCT02075476)

Results Overview

changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

36 months

Results posted on

2020-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Hemiarthroplasty Global Fx(DePuy) in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty
Overall Study STARTED	20	20
Overall Study COMPLETED	17	15
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Hemiarthroplasty Global Fx(DePuy) in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty
Overall Study Death	2	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemiarthroplasty Global Fx(DePuy) n=20 Participants in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) n=19 Participants In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty	Total n=39 Participants Total of all reporting groups
Age, Continuous	76 years n=20 Participants	77 years n=19 Participants	76 years n=39 Participants
Sex: Female, Male Female	14 Participants n=20 Participants	13 Participants n=19 Participants	27 Participants n=39 Participants
Sex: Female, Male Male	6 Participants n=20 Participants	6 Participants n=19 Participants	12 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	20 participants n=20 Participants	19 participants n=19 Participants	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 36 months

changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Outcome measures

Outcome measures
Measure	Hemiarthroplasty Global Fx(DePuy) n=19 Participants in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) n=20 Participants In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score	66 score on a scale Interval 60.0 to 81.0	77 score on a scale Interval 72.0 to 85.0

PRIMARY outcome

Timeframe: 36 months

changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Outcome measures

Outcome measures
Measure	Hemiarthroplasty Global Fx(DePuy) n=19 Participants in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) n=20 Participants In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty
Effectiveness Will be Measured for Constant Score	53 score on a scale Interval 45.0 to 59.0	70 score on a scale Interval 65.0 to 80.0

PRIMARY outcome

Timeframe: 36 months

changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)

Outcome measures

Outcome measures
Measure	Hemiarthroplasty Global Fx(DePuy) n=19 Participants in this technique the prosthesis is implanted in similar approach to shoulder anatomy Hemiarthroplasty	Reverse Arthroplasty Delta Xtent(DePuy) n=20 Participants In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy reverse arthroplasty
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score	26 score on a scale Interval 13.0 to 33.0	13 score on a scale Interval 10.0 to 26.0

Adverse Events

Hemiarthroplasty Global Fx(DePuy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reverse Arthroplasty Delta Xtent(DePuy)

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. Carlos Álvarez

Hospital Gregorio Marañón

Phone: 0034915868000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place