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

Phase 4

Completed

• Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders
• Interventions: Procedure: RF micro-tenotomy

• Registration Number: NCT01554670
• Lead Sponsor: Beijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Status Verified: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Last Update Submitted: 2012-03-18
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
decompression+RF micro-tenotomy	RF micro-tenotomy	A thorough subacromial decompression was performed as described by Neer (which include coracoacromial ligament resection, excision of the anterio-lateral tip of the acromion and thorough debridement of the bursa).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

Primary Outcome Measures

Name	Time	Method
VAS pain score	postoperative 3-week

Secondary Outcome Measures

Name	Time	Method
Shoulder range of motion (ROM)	3-month, 6-month, 1-year
ASES score	3-month, 6-month, 1-year
UCLA score	UCLA score
Constant-Murley score	3-month, 6-month, 1-year
SST score	3-month, 6-month, 1-year