Trial Outcomes & Findings for Retrospective Encore Reverse Shoulder Prosthesis Study (NCT NCT00765037)

NCT ID: NCT00765037

Last Updated: 2010-08-25

Results Overview

Number of subjects who completed all study visits through the 1 year visit.

• Recruitment status: COMPLETED
• Target enrollment: 19 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2010-08-25

Participant Flow

Participant milestones

Measure	Encore RSP Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
Overall Study STARTED	19
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Encore RSP Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
Overall Study Lost to Follow-up	5
Overall Study Adverse Event	1

Baseline Characteristics

Retrospective Encore Reverse Shoulder Prosthesis Study

Baseline characteristics by cohort

Measure	Encore RSP n=19 Participants Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age Continuous	75 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Number of subjects who completed all study visits through the 1 year visit.

Outcome measures

Measure	Encore RSP n=13 Participants Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
Survivorship of the Encore Reverse Shoulder Prosthesis	13 participants

Adverse Events

Encore RSP

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Encore RSP n=19 participants at risk Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
Musculoskeletal and connective tissue disorders Back and Bilateral knee pain	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Respiratory, thoracic and mediastinal disorders Bilateral pulmonary emboli	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Renal and urinary disorders Bronchitis and bladder infection	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Forearm and Jaw fracture	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Increased left shoulder pain	15.8% 3/19 • Number of events 3 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Increased right knee pain	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Increased right shoulder pain	10.5% 2/19 • Number of events 2 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Left knee pain	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Injury, poisoning and procedural complications Multiple contusions	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Nasal fracture	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Nervous system disorders Parkinson's Disease	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Right humeral fracture	10.5% 2/19 • Number of events 2 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Right middle trigger finger pain	10.5% 2/19 • Number of events 2 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Nervous system disorders Right radial nerve palsy	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders Right shoulder instability	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Infections and infestations Staph infection at IV site	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Musculoskeletal and connective tissue disorders left elbow and hand pain	5.3% 1/19 • Number of events 1 • The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.

Additional Information

Jane M. Jacob - Manager of Clinical Affairs

DJO Surgical

Phone: 512-834-6323

Email: jane.jacob@djosurgical.com

Results disclosure agreements

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

Restriction type: LTE60