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

Primary Purpose

Rotator Cuff Shoulder Syndrome and Allied Disorders

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
RF micro-tenotomy
Sponsored by
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Shoulder Syndrome and Allied Disorders focused on measuring Arthroscopic subacromial decompression, Bipolar radiofrequency, Tendon debridement, Shoulder surgery

Eligibility Criteria

26 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    arthroscopic subacromial decompression

    decompression+RF micro-tenotomy

    Arm Description

    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).

    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

    Outcomes

    Primary Outcome Measures

    VAS pain score

    Secondary Outcome Measures

    Shoulder range of motion (ROM)
    ASES score
    UCLA score
    Constant-Murley score
    SST score

    Full Information

    First Posted
    March 1, 2012
    Last Updated
    March 18, 2012
    Sponsor
    Beijing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01554670
    Brief Title
    Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
    Acronym
    RF
    Official Title
    A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Shoulder Syndrome and Allied Disorders
    Keywords
    Arthroscopic subacromial decompression, Bipolar radiofrequency, Tendon debridement, Shoulder surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    arthroscopic subacromial decompression
    Arm Type
    No Intervention
    Arm Description
    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).
    Arm Title
    decompression+RF micro-tenotomy
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    RF micro-tenotomy
    Other Intervention Name(s)
    RF-based plasma micro-tenotomy
    Intervention Description
    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 Measure Information:
    Title
    VAS pain score
    Time Frame
    postoperative 3-week
    Secondary Outcome Measure Information:
    Title
    Shoulder range of motion (ROM)
    Time Frame
    3-month, 6-month, 1-year
    Title
    ASES score
    Time Frame
    3-month, 6-month, 1-year
    Title
    UCLA score
    Time Frame
    UCLA score
    Title
    Constant-Murley score
    Time Frame
    3-month, 6-month, 1-year
    Title
    SST score
    Time Frame
    3-month, 6-month, 1-year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chunyan Jiang, MD, PhD
    Organizational Affiliation
    Beijing JST Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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