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

NCT01554670 | Completed Phase 4

• 2 other identifiers: radio-frequency micro-tenotomyshoulder impingement
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Keywords

Arthroscopic subacromial decompression; Bipolar radiofrequency; Tendon debridement; Shoulder surgery

Outcome Measures

Primary Outcomes (1)

• VAS pain score

  postoperative 3-week

Secondary Outcomes (5)

• 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

Study Arms (2)

arthroscopic subacromial decompression

NO INTERVENTION

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).

decompression+RF micro-tenotomy

ACTIVE COMPARATOR

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

Procedure: RF micro-tenotomy

Interventions

RF micro-tenotomy 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

Also known as: RF-based plasma micro-tenotomy

decompression+RF micro-tenotomy

Eligibility Criteria

• Age: 26 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a skeletally mature patient who agreed to participate in the study
• 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
• supraspinatous tendinosis was confirmed on preoperative MRI
• the symptoms were not relieved by a standardized conservative treatment regime
• patient underwent standard arthroscopic subacromial decompression surgery.

You may not qualify if:

• any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding
• concomitant biceps lesions or internal impingement
• any history of surgical treatment on the same shoulder.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Officials

• Chunyan Jiang, MD, PhD

  Beijing JST Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the physician

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03