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RSP® Prospective Multi-Center Study

2014-08-27 03:18:16 | BioPortfolio

Summary

The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).

Description

Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Rotator Cuff Deficiency

Intervention

Encore Reverse Shoulder Prosthesis (RSP®)

Location

Coastal Orthopedics & Sports Medicine
Bradenton
Florida
United States
34209

Status

Recruiting

Source

Encore Medical, L.P.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:16-0400

Clinical Trials [1418 Associated Clinical Trials listed on BioPortfolio]

Retrospective Encore Reverse Shoulder Prosthesis Study

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already...

Reverse Shoulder Prosthesis Study

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical re...

Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair

To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods - abduction shoulder brace versus simp...

Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is ...

Outcomes in Rotator Cuff Repair Using Graft Reinforcement

The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.

PubMed Articles [4163 Associated PubMed Articles listed on BioPortfolio]

Allograft Use in Shoulder Surgery: Instability and Rotator Cuff.

Shoulder instability and rotator cuff pathology can provide a challenging problem, especially in the revision setting. Allograft use in primary or revision surgical intervention for shoulder instabili...

Instability in Reverse Total Shoulder Arthroplasty.

Recently, indications for reverse total shoulder arthroplasty have expanded to include glenohumeral arthritis, rotator cuff arthropathy, irreparable rotator cuff tears, complex proximal humerus fractu...

A Rotator Cuff Tear Concomitant With Shoulder Stiffness Is Associated With a Lower Retear Rate After 1-Stage Arthroscopic Surgery.

Few studies have reported on the radiological characteristics and repair integrity of coexistent rotator cuff tears (RCTs) and shoulder stiffness after simultaneous arthroscopic rotator cuff repair an...

Rotator Cuff Matrix Augmentation and Interposition: A Systematic Review and Meta-analysis.

Surgical management of rotator cuff tears is controversial and complex, ranging from nonoperative management to reverse shoulder arthroplasty.

Large Critical Shoulder Angle Has Higher Risk of Tendon Retear After Arthroscopic Rotator Cuff Repair.

The critical shoulder angle (CSA) is the angle created between the superior and inferior bone margins of the glenoid and the most lateral border of the acromion. A few studies recently investigated th...

Medical and Biotech [MESH] Definitions

Rapidly destructive shoulder joint and bone disease found mainly in elderly, and predominantly in women. It is characterized by SHOULDER PAIN; JOINT INSTABILITY; and the presence of crystalline CALCIUM PHOSPHATES in the SYNOVIAL FLUID. It is associated with ROTATOR CUFF INJURIES.

Compression of the rotator cuff tendons and subacromial bursa between the humeral head and structures that make up the coracoacromial arch and the humeral tuberosities. This condition is associated with subacromial bursitis and rotator cuff (largely supraspinatus) and bicipital tendon inflammation, with or without degenerative changes in the tendon. Pain that is most severe when the arm is abducted in an arc between 40 and 120 degrees, sometimes associated with tears in the rotator cuff, is the chief symptom. (From Jablonski's Dictionary of Syndromes and Eponymic Diseases, 2d ed)

Injuries to the ROTATOR CUFF of the shoulder joint.

The musculotendinous sheath formed by the supraspinatus, infraspinatus, subscapularis, and teres minor muscles. These help stabilize the head of the HUMERUS in the glenoid fossa and allow for rotation of the SHOULDER JOINT about its longitudinal axis.

Replacement for a SHOULDER JOINT.

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Relevant Topics

Arthroplasty
Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. Osteo...

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