Plantar Fasciosis, Achilles TendinosisPhase 4TOPAZ RegistryNCT00420875
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
A Phase 4 study testing TOPAZ MicroDebrider in people with Plantar Fasciosis, Achilles Tendinosis, run by ArthroCare Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciosis, Achilles Tendinosis
- What is being tested?
- TOPAZ MicroDebrider
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Foot Care Physicians
Mesa, Arizona, 85204
Foot and Ankle Clinic of Oakwood
Oakwood, Georgia, 30566
Foot and Ankle Institute of Santa Monica
Santa Monica, California, 90403
About this study
Official title: "Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis"
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.
Read the 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.
- Conditions
- Plantar Fasciosis, Achilles Tendinosis
- Being tested
- TOPAZ MicroDebrider
- Keywords
- plantar fasciitis, plantar fasciosis, Achilles tendinosis, Achilles tendinitis, heel pain, fasciosis, fasciitis, tendinosis, tendinitis, conservative treatment
- Medical subject headings
- Fasciitis, Plantar, Fasciitis, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPAZ MicroDebriderDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Hind Foot Scale (AHS)
Measured: 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcomes (1)
Visual Analog Scale (VAS), SF-36 Quality of Life, Patient Satisfaction
Measured: 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJun 2007
Why it stopped: Did not meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciosis, Achilles TendinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Babak Baravarian, DPM, Principal investigator, Foot and Ankle Institute of Santa Monica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420875
- Sponsor's protocol ID
- SM-706WW
- Acronym
- TOPAZ Registry
- Status last verified
- Aug 2015
- First submitted
- 9 Jan 2007
- Last updated
- 26 Aug 2015
- Results posted
- No
Publications
Aldridge T. Diagnosing heel pain in adults. Am Fam Physician. 2004 Jul 15;70(2):332-8.
PubMed 15291091Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
PubMed 12756315Yu JS. Pathologic and post-operative conditions of the plantar fascia: review of MR imaging appearances. Skeletal Radiol. 2000 Sep;29(9):491-501. doi: 10.1007/s002560000230.
PubMed 11000294LeMelle DP, Kisilewicz P, Janis LR. Chronic plantar fascial inflammation and fibrosis. Clin Podiatr Med Surg. 1990 Apr;7(2):385-9.
PubMed 2346891Schepsis AA, Leach RE, Gorzyca J. Plantar fasciitis. Etiology, treatment, surgical results, and review of the literature. Clin Orthop Relat Res. 1991 May;(266):185-96.
PubMed 2019049Strash WW, Perez RR. Extracorporeal shockwave therapy for chronic proximal plantar fasciitis. Clin Podiatr Med Surg. 2002 Oct;19(4):467-76. doi: 10.1016/s0891-8422(02)00016-2.
PubMed 12471854Lewis G, Gatti A, Barry LD, Greenberg PM, Levenson M. The plantar approach to heel surgery: a retrospective study. J Foot Surg. 1991 Nov-Dec;30(6):542-6.
PubMed 1770205Regan W, Wold LE, Coonrad R, Morrey BF. Microscopic histopathology of chronic refractory lateral epicondylitis. Am J Sports Med. 1992 Nov-Dec;20(6):746-9. doi: 10.1177/036354659202000618.
PubMed 1280910Goldberg EJ, Abraham E, Siegel I. The surgical treatment of chronic lateral humeral epicondylitis by common extensor release. Clin Orthop Relat Res. 1988 Aug;(233):208-12.
PubMed 3402125Galliani I, Burattini S, Mariani AR, Riccio M, Cassiani G, Falcieri E. Morpho-functional changes in human tendon tissue. Eur J Histochem. 2002;46(1):3-12. doi: 10.4081/1649.
PubMed 12044045Nirschl RP, Ashman ES. Elbow tendinopathy: tennis elbow. Clin Sports Med. 2003 Oct;22(4):813-36. doi: 10.1016/s0278-5919(03)00051-6.
PubMed 14560549Stone PA, McClure LP. Retrospective review of endoscopic plantar fasciotomy. 1994 through 1997. J Am Podiatr Med Assoc. 1999 Feb;89(2):89-93. doi: 10.7547/87507315-89-2-89.
PubMed 10063779Gould JS. Chronic plantar fasciitis. Am J Orthop (Belle Mead NJ). 2003 Jan;32(1):11-3. No abstract available.
PubMed 12580344Hammer DS, Adam F, Kreutz A, Rupp S, Kohn D, Seil R. Ultrasonographic evaluation at 6-month follow-up of plantar fasciitis after extracorporeal shock wave therapy. Arch Orthop Trauma Surg. 2005 Feb;125(1):6-9. doi: 10.1007/s00402-003-0591-z. Epub 2003 Oct 3.
PubMed 14530990Hyer CF, Vancourt R, Block A. Evaluation of ultrasound-guided extracorporeal shock wave therapy (ESWT) in the treatment of chronic plantar fasciitis. J Foot Ankle Surg. 2005 Mar-Apr;44(2):137-43. doi: 10.1053/j.jfas.2005.01.005.
PubMed 15768363
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis"
- ClinicalTrials.gov ID
- NCT00420875
- Acronym / sponsor ID
- TOPAZ Registry / SM-706WW
- Conditions
- Plantar Fasciosis, Achilles Tendinosis
- Keywords
- plantar fasciitis, plantar fasciosis, Achilles tendinosis, Achilles tendinitis, heel pain, fasciosis, fasciitis, tendinosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not meet enrollment goals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Jun 2007
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOPAZ MicroDebriderThe 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. | Device | – |
Primary outcome
Ankle Hind Foot Scale (AHS)
Time frame: 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 15291091Aldridge T. Diagnosing heel pain in adults. Am Fam Physician. 2004 Jul 15;70(2):332-8.
- Background: PubMed 12756315Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
- Background: PubMed 11000294Yu JS. Pathologic and post-operative conditions of the plantar fascia: review of MR imaging appearances. Skeletal Radiol. 2000 Sep;29(9):491-501. doi: 10.1007/s002560000230.
- Background: PubMed 2346891LeMelle DP, Kisilewicz P, Janis LR. Chronic plantar fascial inflammation and fibrosis. Clin Podiatr Med Surg. 1990 Apr;7(2):385-9.
- Background: PubMed 2019049Schepsis AA, Leach RE, Gorzyca J. Plantar fasciitis. Etiology, treatment, surgical results, and review of the literature. Clin Orthop Relat Res. 1991 May;(266):185-96.
- Background: PubMed 12471854Strash WW, Perez RR. Extracorporeal shockwave therapy for chronic proximal plantar fasciitis. Clin Podiatr Med Surg. 2002 Oct;19(4):467-76. doi: 10.1016/s0891-8422(02)00016-2.
- Background: PubMed 1770205Lewis G, Gatti A, Barry LD, Greenberg PM, Levenson M. The plantar approach to heel surgery: a retrospective study. J Foot Surg. 1991 Nov-Dec;30(6):542-6.
- Background: PubMed 1280910Regan W, Wold LE, Coonrad R, Morrey BF. Microscopic histopathology of chronic refractory lateral epicondylitis. Am J Sports Med. 1992 Nov-Dec;20(6):746-9. doi: 10.1177/036354659202000618.
- Background: PubMed 3402125Goldberg EJ, Abraham E, Siegel I. The surgical treatment of chronic lateral humeral epicondylitis by common extensor release. Clin Orthop Relat Res. 1988 Aug;(233):208-12.
- Background: PubMed 12044045Galliani I, Burattini S, Mariani AR, Riccio M, Cassiani G, Falcieri E. Morpho-functional changes in human tendon tissue. Eur J Histochem. 2002;46(1):3-12. doi: 10.4081/1649.
- Background: PubMed 14560549Nirschl RP, Ashman ES. Elbow tendinopathy: tennis elbow. Clin Sports Med. 2003 Oct;22(4):813-36. doi: 10.1016/s0278-5919(03)00051-6.
- Background: PubMed 10063779Stone PA, McClure LP. Retrospective review of endoscopic plantar fasciotomy. 1994 through 1997. J Am Podiatr Med Assoc. 1999 Feb;89(2):89-93. doi: 10.7547/87507315-89-2-89.
- Click here for information about TOPAZ (the device to be used in the study)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Baravarian, DPM principal investigator
Foot and Ankle Institute of Santa Monica
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TOPAZ MicroDebrider in people with Plantar Fasciosis, Achilles Tendinosis, run by ArthroCare Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Hind Foot Scale (AHS) (time frame: 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00420875, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.