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

NCT ID: NCT01554670

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-02-28

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.

Conditions

Rotator Cuff Shoulder Syndrome and Allied Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

arthroscopic subacromial decompression

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

decompression+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

Group Type: ACTIVE_COMPARATOR

RF micro-tenotomy

Intervention Type: PROCEDURE

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

Interventions

RF micro-tenotomy

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

Intervention Type: PROCEDURE

Other Intervention Names

RF-based plasma micro-tenotomy

Eligibility Criteria

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.

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yi Lu

Deputy director of the physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunyan Jiang, MD, PhD

Role: STUDY_DIRECTOR

Beijing JST Hospital

Other Identifiers

shoulder impingement

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

radio-frequency micro-tenotomy

Identifier Type: -

Identifier Source: org_study_id