Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome

Beijing Hospital65 enrolled

Overview

The purpose of this study is to determine whether radio-frequency (RF)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40). Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Shoulder Syndrome and Allied Disorders

Interventions

an additional bipolar RF-based device (TOPAZ, Arthrocare, Austin, TX) connected to a System2000 generator (Arthrocare, Austin, TX) was used to perform the micro-tenotomy. The device functions using a controlled plasma-mediated RF-based process (Co-ablation).The device was placed on the tendon perpendicular to its surface, for 500 milliseconds, and micro-debridement was performed at 5-mm intervals by a 2-row fashion, which covered most of the foot-print region of the supraspinatous tendon and at a depth of 3 to 5 mm

Eligibility

Sex: ALLMin age: 26 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. a skeletally mature patient who agreed to participate in the study 2. shoulder impingement syndrome was diagnosed by one senior surgeon (CYJ) and without any sign of rotator cuff tear both on pre-operative MRI or intra-operative arthroscopic view 3. supraspinatous tendinosis was confirmed on preoperative MRI 4. the symptoms were not relieved by a standardized conservative treatment regime 5. patient underwent standard arthroscopic subacromial decompression surgery. Exclusion Criteria: 1. any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding 2. concomitant biceps lesions or internal impingement 3. any history of surgical treatment on the same shoulder.

Outcomes

Primary Outcomes

VAS pain score

Time frame: postoperative 3-week

Secondary Outcomes

Shoulder range of motion (ROM)

Time frame: 3-month, 6-month, 1-year

ASES score

Time frame: 3-month, 6-month, 1-year

UCLA score

Time frame: UCLA score

Constant-Murley score

Time frame: 3-month, 6-month, 1-year

SST score

Time frame: 3-month, 6-month, 1-year