Total vs. Reverse Shoulder Replacement: a Prospective Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- WOOS Score
Study Overview
Brief Summary
Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of glenohumeral osteoarthritis.
Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse Shoulder Arthroplasty.
Detailed Description
The shoulder is the most mobile joint in the human body with a complex arrangement of structures working together to provide the movement necessary for daily life. Great mobility comes at the expense of stability. Several bones and a network of soft tissue (ligaments, tendons, and muscles) work together to produce shoulder movement. They also interact to keep the joint in place while it moves through extreme ranges of motion.
BONES The glenohumeral joint (shoulder joint) is a multiaxial, synovial ball and socket joint and involves articulation between the shoulder blade and the head of the humerus (upper arm bone). This makes it the most mobile joint of the human body.
SOFT TISSUE The rotator cuff is a group of muscles and their tendons that act to stabilize the shoulder. The four muscles of the rotator cuff are over half of the seven scapulohumeral muscles. These tendons can become torn following a trauma to the shoulder or it can occur through the "wear and tear" on tendons, most commonly the supraspinatus tendon found under the acromion. To be considered an equal candidate for both implants the rotator cuff must be grossly intact.
ARTHRITIS Glenohumeral (shoulder) arthritis is a common source of pain and disability that affects up to 20% of the older population. Damage to the cartilage surfaces of the glenohumeral joint (the shoulder's "ball-and-socket" structure) is the primary cause of shoulder arthritis.
SHOULDER REPLACEMENTS There are two types of total shoulder replacement systems: the conventional Total shoulder and the Reverse shoulder. The reverse was originally developed for use in patients with advanced high loss of shoulder function in conjunction with a damaged rotator cuff.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to 95 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 70 or older,
- •have radiographic signs of osteoarthritis (narrowing of the glenohumeral joint space, marginal osteophytes around the humeral head, progressive changes with sclerosis and subcortical cystic formation and flattening of the humeral head),
- •intact rotator cuff but with atrophy or fatty degeneration (defined as Grade II atrophy noted on preoperative shoulder ultrasound),
- •objective weakness as measured with Isobex testing,
- •limited forward elevation (less than 90 degrees)
Exclusion Criteria
- •patients who present with pain secondary to inflammatory arthropathy,
- •obvious full-thickness rotator cuff tear,
- •cuff tear arthropathy,
- •revision arthroplasty,
- •fracture or trauma,
- •patients who had previous rotator cuff repair or prior open surgery prior to shoulder arthroplasty.
- •pregnancy
Outcomes
Primary Outcomes
WOOS Score
Time Frame: 2 years after shoulder replacement
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
ASES Score
Time Frame: 2 years after shoulder replacement
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.
Secondary Outcomes
- Shoulder Strength and Motion Based on Physican Examination(2 years post shoulder replacement)