Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189592
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2005-09-12
Brief Title:
Plantar Fasciosis Treatment Using Coblation
Sponsor:
ArthroCare Corporation
Organization:
ArthroCare Corporation
Study Overview
Official Title:
Plantar Fasciosis Treatment Using Coblation Prospective Double-Blind Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and secondarily to determine whether there may be additional potential benefits stemming from its use
Detailed Description:
Severe recalcitrant heel pain resulting from repetitive trauma to the plantar fascia is a relatively commonly observed phenomenon Although this condition is frequently referred to as heel spurs plantar fasciitis acute inflammatory stage and plantar fasciosis chronic degeneration are currently accepted as the more accurate terms Symptoms most often occur during the first few steps in the morning but may also be effected during intense activity or with prolonged standing The source of pain symptoms which are usually perceived as a gradual onset of burning is located at the origin of the plantar fascia at the calcaneous heel bone Risk factors such as low or high arches or over-pronation of the foot systemic disease or obesity may exacerbate pain
More than two million Americans receive treatment each year for plantar fasciitis and fasciosis Conservative treatment options for plantar fasciosis include rest stretching strengthening and massage progressing to non-steroidal anti-inflammatories steroid injections or iontophoresis with continued recalcitrance Orthotics heel cups night splints and plantar strapping are other conservative options frequently recommended by treating physicians Patient outcomes and response to conservative measures are usually positive with non-responsive cases approximately 10 of all presenting cases receiving surgical care Extracorporeal shockwave treatment has recently been advocated for the recalcitrant cases and has shown to be effective in 60-80 percent of the cases Plantar fascia release either partial or complete is commonly the surgical procedure of choice for treating plantar fasciosis However this surgery has a risk of complications and is thought to alter the biomechanics of the foot which may be linked to post-operative lateral column pain and long-term disability Because of the potential postoperative sequelae with plantar fascia release it is valuable to examine less invasive surgical techniques for treating recalcitrant plantar fasciosis
The concept of using a plasma RF-based microsurgical approach as a viable modality for treating tendinosis and now recalcitrant plantar fasciosis was originally drawn from the research work conducted in patients treated for congestive heart failure using laser or RF-based transmyocardial revascularization TMR The mechanism of action behind the clinical success observed with laser and RF-based TMR was theorized to be associated with the localized angiogenic healing response noted to occur following the procedure Localized angiogenesis had not been observed previously using mechanical devices for TMR which were also less successful clinically To substantiate adopting a TMR-like approach for treating tendinosis the capability of plasma RF-based microsurgery for initiating an angiogenic healing response was examined in vivo using histology and biochemical analysis The sum of several studies provides good evidence to suggest that plasma RF-based microsurgery can promote an angiogenic healing response using an appropriate application
Preliminary clinical experience following plasma RF-based micro-tenotomy has demonstrated excellent success in treating chronic refractive tendinosis 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 These promising clinical findings as well as the evidence from the basic research studies led us to consider evaluating this plasma RF-based approach for treating symptomatic chronic recalcitrant heel pain resembling plantar fasciosis The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recalcitrant plantar fasciosis and secondarily to determine whether there may be additional potential benefits stemming from its use such as reduced incidence of postoperative complications and improved function compared to conventional surgery
More than two million Americans receive treatment each year for plantar fasciitis and fasciosis Conservative treatment options for plantar fasciosis include rest stretching strengthening and massage progressing to non-steroidal anti-inflammatories steroid injections or iontophoresis with continued recalcitrance Orthotics heel cups night splints and plantar strapping are other conservative options frequently recommended by treating physicians Patient outcomes and response to conservative measures are usually positive with non-responsive cases approximately 10 of all presenting cases receiving surgical care Extracorporeal shockwave treatment has recently been advocated for the recalcitrant cases and has shown to be effective in 60-80 percent of the cases Plantar fascia release either partial or complete is commonly the surgical procedure of choice for treating plantar fasciosis However this surgery has a risk of complications and is thought to alter the biomechanics of the foot which may be linked to post-operative lateral column pain and long-term disability Because of the potential postoperative sequelae with plantar fascia release it is valuable to examine less invasive surgical techniques for treating recalcitrant plantar fasciosis
The concept of using a plasma RF-based microsurgical approach as a viable modality for treating tendinosis and now recalcitrant plantar fasciosis was originally drawn from the research work conducted in patients treated for congestive heart failure using laser or RF-based transmyocardial revascularization TMR The mechanism of action behind the clinical success observed with laser and RF-based TMR was theorized to be associated with the localized angiogenic healing response noted to occur following the procedure Localized angiogenesis had not been observed previously using mechanical devices for TMR which were also less successful clinically To substantiate adopting a TMR-like approach for treating tendinosis the capability of plasma RF-based microsurgery for initiating an angiogenic healing response was examined in vivo using histology and biochemical analysis The sum of several studies provides good evidence to suggest that plasma RF-based microsurgery can promote an angiogenic healing response using an appropriate application
Preliminary clinical experience following plasma RF-based micro-tenotomy has demonstrated excellent success in treating chronic refractive tendinosis 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 These promising clinical findings as well as the evidence from the basic research studies led us to consider evaluating this plasma RF-based approach for treating symptomatic chronic recalcitrant heel pain resembling plantar fasciosis The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recalcitrant plantar fasciosis and secondarily to determine whether there may be additional potential benefits stemming from its use such as reduced incidence of postoperative complications and improved function compared to conventional surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None