Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis (TOPAZ Registry)
Primary Purpose
Plantar Fasciosis, Achilles Tendinosis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TOPAZ MicroDebrider
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciosis, Achilles Tendinosis focused on measuring plantar fasciitis, plantar fasciosis, Achilles tendinosis, Achilles tendinitis, heel pain, fasciosis, fasciitis, tendinosis, tendinitis, conservative treatment
Eligibility Criteria
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject's history and physical examination pinpoints anatomic origin of heel pain as associated with plantar fasciosis (tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion) or Achilles tendinosis (tenderness upon palpation and local pressure at the insertion site)
- Subject (or guardian) must sign IRB approved informed consent form
- Subject is willing and able to complete required follow-up
Exclusion Criteria:
- Previous fascia surgery on pathology to be treated by this study
- Multiple anatomic origins of heel pain in foot to be treated by study
- History or documentation showing Type I and Type II Diabetes Mellitus
- Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
- History or documentation showing peripheral vascular disease or autoimmune disease
- History or documentation of fibromyalgia
- Subject is currently participating in another drug/device study related to the injured plantar fascia or Achilles tendon
- Pregnant or pregnant suspected subjects prior to treatment
- Subject is incapable of understanding or responding to the study questionnaires
Sites / Locations
- Foot Care Physicians
- Foot and Ankle Institute of Santa Monica
- Foot and Ankle Clinic of Oakwood
Outcomes
Primary Outcome Measures
Ankle Hind Foot Scale (AHS)
Secondary Outcome Measures
Visual Analog Scale (VAS), SF-36 Quality of Life, Patient Satisfaction
Full Information
NCT ID
NCT00420875
First Posted
January 9, 2007
Last Updated
August 25, 2015
Sponsor
ArthroCare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00420875
Brief Title
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Acronym
TOPAZ Registry
Official Title
"Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Did not meet enrollment goals
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
ArthroCare Corporation
4. Oversight
5. Study Description
Brief Summary
To determine the magnitude of improvement for pain and function symptoms over a two year period after enrollment into the registry study in patients presenting with chronic heel pain and receiving standard of care treatment. Standard of care will include traditional conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.
Detailed Description
Several million Americans receive treatment for heel pain each year, with more than two million patients treated each year for plantar fasciitis and fasciosis alone.(2) Conservative treatment options for recalcitrant heel pain include rest, stretching, strengthening and massage, progressing to non-steroidal anti-inflammatory drugs (NSAIDs), cox-2 inhibitors, steroid injections or iontophoresis with continued recalcitrance.(3;4) Orthotics, heel cups, night splints and plantar strapping are other conservative options frequently recommended by treating physicians.(4) Patient outcomes and response to conservative measures is usually positive, with non-responsive cases, approximately 2% - 10% of all presenting cases, receiving surgical care. Extracorporeal shockwave treatment (ESWT) has recently been advocated for the recalcitrant cases and has shown to be effective in 60-80 percent of the cases.(5-7) In general, non-surgical treatment of plantar fasciosis and tendinosis is believed to be unsuccessful, so that surgical treatment is required in about 25% of patients; however, results of traditional surgical treatments have been reported to deteriorate with time.(8)
Clinical experience following RF-based plasma microtenotomy has demonstrated excellent success in treating chronic, refractive tendinosis of the lateral epicondyle in the elbow.(9) The investigators reported that this technique was technically simple to perform and was much less invasive than conventional surgery. Patients had a rapid and uncomplicated recovery and reported minimal to no pain 7-10 days following the procedure; their pain relief persisted or improved through 24 months. Magnetic resonance imaging correlated well with clinical results. The RF-based plasma microtenotomy procedure is also being used successfully in tendons in the shoulder, knee, foot and ankle and in the plantar fascia. A randomized controlled study was conducted with the aim of determining whether bRF-based microtenotomy was effective for treating chronic supraspinatus tendinosis (10). Longitudinal postoperative recovery through one year for patients treated using RF-based plasma microtenotomy was compared to patients undergoing subacromial decompression. Both patient groups demonstrated significant improvement after each respective procedure and longitudinal recovery profiles were statistically similar. Early experience using this procedure for foot and ankle tendons, including the Achilles tendon, posterior tibial tendon, peroneal tendon, and plantar fascia revealed over 90% good to excellent results, reflecting the results shown by patients treated for tendinosis in the elbow (11)
Further investigation of optimal placement of this surgical approach into the standard of care treatment paradigm for treating plantar fasciosis and Achilles tendinosis would be beneficial. It is not known whether this RF-based plasma microsurgery might be more optimally placed earlier on within the standard of care treatment algorithm.
The purpose of this study is to determine the magnitude of improvement for pain and functional symptoms over a two year period after enrollment into the registry study in patients presenting with chronic heel pain and undergoing standard of care treatment. Standard of care will include traditional conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciosis, Achilles Tendinosis
Keywords
plantar fasciitis, plantar fasciosis, Achilles tendinosis, Achilles tendinitis, heel pain, fasciosis, fasciitis, tendinosis, tendinitis, conservative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
TOPAZ MicroDebrider
Intervention Description
The TOPAZ MicroDebrider will be used for patients that fail conservative care. Under sterile conditions in the operating room, patients will be given intravenous sedation (drugs that make you sleepy and unaware of your surroundings) in a hand vein and local anesthetic (drugs to numb the area where the surgical procedure will be done). Depending on the technique used the study doctor may or may not make an incision (cut) about 1 inch long on the side of your foot to expose your tendon. If the study doctor chooses to use the percutaneous method, an incision will not be made. The study doctor will put the tip of the TOPAZ MicroDebrider device (which is about 1/16th of an inch long) into the tendon. A current of energy will be applied on and around the tendon. Steri strips will be placed on the skin to close the area treated.
Primary Outcome Measure Information:
Title
Ankle Hind Foot Scale (AHS)
Time Frame
6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS), SF-36 Quality of Life, Patient Satisfaction
Time Frame
6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is at least 18 years of age
Subject's history and physical examination pinpoints anatomic origin of heel pain as associated with plantar fasciosis (tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion) or Achilles tendinosis (tenderness upon palpation and local pressure at the insertion site)
Subject (or guardian) must sign IRB approved informed consent form
Subject is willing and able to complete required follow-up
Exclusion Criteria:
Previous fascia surgery on pathology to be treated by this study
Multiple anatomic origins of heel pain in foot to be treated by study
History or documentation showing Type I and Type II Diabetes Mellitus
Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
History or documentation showing peripheral vascular disease or autoimmune disease
History or documentation of fibromyalgia
Subject is currently participating in another drug/device study related to the injured plantar fascia or Achilles tendon
Pregnant or pregnant suspected subjects prior to treatment
Subject is incapable of understanding or responding to the study questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Baravarian, DPM
Organizational Affiliation
Foot and Ankle Institute of Santa Monica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foot Care Physicians
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States
Facility Name
Foot and Ankle Institute of Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Foot and Ankle Clinic of Oakwood
City
Oakwood
State/Province
Georgia
ZIP/Postal Code
30566
Country
United States
12. IPD Sharing Statement
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Links:
URL
http://topazinfo.com
Description
Click here for information about TOPAZ (the device to be used in the study)
Learn more about this trial
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
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