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Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery

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ClinicalTrials.gov Identifier: NCT01884077
Recruitment Status : Terminated (slow recruitment and poor follow up)
First Posted : June 21, 2013
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis
Interventions Device: Reverse Shoulder Arthroplasty
Device: Total Shoulder Arthroplasty
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Hide Arm/Group Description

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Period Title: Overall Study
Started 8 11
Completed 0 1
Not Completed 8 10
Reason Not Completed
screen fail             0             2
canceled surgery             2             0
Lost to Follow-up             0             4
study closed             6             4
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty Total
Hide Arm/Group Description

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
8
 100.0%
11
 100.0%
19
 100.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 19 participants
72
(69 to 75)
77
(72 to 82)
75.5
(69 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
2
  25.0%
6
  54.5%
8
  42.1%
Male
6
  75.0%
5
  45.5%
11
  57.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 11 participants 19 participants
8
 100.0%
11
 100.0%
19
 100.0%
1.Primary Outcome
Title ASES Score
Hide Description American Shoulder & Elbow Survey (ASES): Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder & elbow in different planes of motion. Pain and weakness with various activities are also addressed. ASES score will be calculated, compared and reported for both groups pre-operatively and 2 years post operatively: (17 patients) total arthroplasty and (17 patients) reverse arthroplasty.
Time Frame 2 years after shoulder replacement
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been discontinued and data was not sufficiently collected for any participant.
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Hide Arm/Group Description:

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title WOOS Score
Hide Description

a disease-specific quality-of-life instrument (Western Ontario Osteoarthritis of the Shoulder [WOOS]. WOOS Score will be generated for both groups pre-operatively and 2 years post operatively: Reverse arthroplasty(17 patients) and Total arthroplasty (17 patients)

Study has been discontinued

Time Frame 2 years after shoulder replacement
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Hide Arm/Group Description:

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Shoulder Strength and Motion Based on Physican Examination
Hide Description Research team member measures both shoulder range of motion (using a goniometer) and strength based on the standardized American Shoulder and Elbow Surgeons Society (ASES)examination. Physical Examination includes the following: forward elevation, external rotation, internal rotation, external rotation at side, Internal rotation extension with lift off exam, Horn Blower's, external rotation strength, thumb down abduction strength, abdominal compression test, Biceps rupture, Speeds Test, and Yergason's Test. External and Thumb Down abduction are measured with Iso-Force machine. Preoperative and 2 year post-operative range of motion and strength measurement score averages will be compared and reported for both groups (total 34 patients).
Time Frame 2 years post shoulder replacement
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Hide Arm/Group Description:

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3.5 years
Adverse Event Reporting Description No adverse events
 
Arm/Group Title Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Hide Arm/Group Description

Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder

Total Shoulder Arthroplasty: TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.

Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint

Reverse Shoulder Arthroplasty: REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).

All-Cause Mortality
Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Hide Serious Adverse Events
Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reverse Shoulder Arthroplasty Total Shoulder Arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
This study was terminated due to slow enrollment and poor follow up. There is insufficient data for analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aaron Chamberlain
Organization: Washington University School of Medicine - Dept of Orthopaedic Surgery
Phone: 314-362-9283
EMail: chamberlaina@wudosis.wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01884077    
Other Study ID Numbers: 201209102
First Submitted: June 12, 2013
First Posted: June 21, 2013
Results First Submitted: May 8, 2017
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018