Achilles PainPhase 4NCT00534781
Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement
A Phase 4 study testing plasma microdebrider and Mechanical Surgical Debridement in people with Achilles Pain and Achilles Tendinosis, run by ArthroCare Corporation at 2 sites in United States.
Trial summary
This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Pain, Achilles Tendinosis, Heel Pain
- What is being tested?
- plasma microdebrider and Mechanical Surgical Debridement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Sep 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Subject presents with pain associated with the Achilles tendon graded as >5 on a 0 to 10- point scale
- Subject's history and physical examination pinpoints anatomic origin of Achilles pain as associated with degeneration of the Achilles (non-insertional - proximal to retrocalcaneal bursa)
- Magnetic resonance imaging findings consistent with tendinosis
- Subject (or guardian) must sign IRB approved informed consent form
- Subject is willing and able to complete required follow-up
Who cannot join
- Use of NSAID's (e.g., ibuprofen, naproxen) within 2 weeks prior to treatment by this study
- Previous Achilles surgery on pathology to be treated by this study
- Heel pain associated with plantar fasciosis
- Multiple anatomic origins of 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)
Show all 11Show fewer
- History or documentation showing peripheral vascular disease or autoimmune disease
- Subject is currently participating in another drug/device study related to the degenerated Achilles
- Pregnant or pregnant suspected subjects prior to treatment
- History of Extracorporeal Shock Wave Treatment (ESWT) on foot to be treated by study
- Subject is incapable of understanding or responding to the study questionnaires
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, 21218
Orthopaedic Foot and Ankle Center
Columbus, Ohio, 43231
About this study
Official title: Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other therapy.
Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.
Read the detailed description
Typically, Achilles pain results from overuse of the calf muscles (e.g., running, jumping) or abnormal biomechanical stress on the foot and ankle.(1). Overuse can injure the fibrous tissue that connects the heel to the calf muscles. Treating an injured Achilles tendon is crucial to avoid exacerbating the injury further, which may lead to partial or full rupture of the tendon.
Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic Achilles tendinopathy; the paratenon is rarely involved. Important features are a lack of inflammatory cells and a poor intrinsic ability to heal.
Several million Americans receive treatment for tendinosis each year, with more than 200,000 patients treated each year for Achilles tendonitis and tendinosis alone.(5) Conservative treatment options for Achilles pain include rest, stretching, strengthening, ice and/or physical therapy. In general, non-surgical treatment of Achilles tendonitis 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. (3).
The purpose of this study is to evaluate longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores in patients with symptomatic Achilles tendinosis treated using radiofrequency-based plasma microtenotomy compared to standard surgical debridement.
- Conditions
- Achilles Pain, Achilles Tendinosis, Heel Pain
- Being tested
- plasma microdebrider, Mechanical Surgical Debridement
- Keywords
- Achilles, Tendinosis, Tendinitis, Achilles Tendinosis, Achilles Tendinitis, Coblation, Bipolar Radiofrequency, Surgical Debridement, Debridement, Heel Pain, Achilles Pain
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma microdebriderDevice
Also called TOPAZ MicroDebrider
Coblation of the Achilles
Mechanical Surgical DebridementProcedure or surgery
Surgical Debridement of the Achilles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | plasma microtenotomy Receives: Device: plasma microdebrider |
| B | Active comparator | Standard Surgical Debridement Receives: Procedure: Mechanical Surgical Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether patients treated using plasma microtenotomy demonstrate equivalent longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores through 12 months postoperatively to patients treated using standard surgical debridement.
Measured: 12 months
Secondary outcomes (1)
To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Philbin, D.O., Principal investigator, Orthopedic Foot and Ankle Center, Columbus, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534781
- Sponsor's protocol ID
- SM-107WW
- Status last verified
- Jul 2013
- First submitted
- 24 Sep 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
- ClinicalTrials.gov ID
- NCT00534781
- Acronym / sponsor ID
- SM-107WW
- Conditions
- Achilles Pain, Achilles Tendinosis, Heel Pain
- Keywords
- Achilles, Tendinosis, Tendinitis, Achilles Tendinosis, Achilles Tendinitis, Coblation, Bipolar Radiofrequency, Surgical Debridement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Sep 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.
This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other therapy.
Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.
Detailed description
Typically, Achilles pain results from overuse of the calf muscles (e.g., running, jumping) or abnormal biomechanical stress on the foot and ankle.(1). Overuse can injure the fibrous tissue that connects the heel to the calf muscles. Treating an injured Achilles tendon is crucial to avoid exacerbating the injury further, which may lead to partial or full rupture of the tendon.
Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic Achilles tendinopathy; the paratenon is rarely involved. Important features are a lack of inflammatory cells and a poor intrinsic ability to heal.
Several million Americans receive treatment for tendinosis each year, with more than 200,000 patients treated each year for Achilles tendonitis and tendinosis alone.(5) Conservative treatment options for Achilles pain include rest, stretching, strengthening, ice and/or physical therapy. In general, non-surgical treatment of Achilles tendonitis 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. (3).
The purpose of this study is to evaluate longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores in patients with symptomatic Achilles tendinosis treated using radiofrequency-based plasma microtenotomy compared to standard surgical debridement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: plasma microdebriderplasma microtenotomy |
| B | Active comparator | Procedure: Mechanical Surgical DebridementStandard Surgical Debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age
- Subject presents with pain associated with the Achilles tendon graded as >5 on a 0 to 10- point scale
- Subject's history and physical examination pinpoints anatomic origin of Achilles pain as associated with degeneration of the Achilles (non-insertional - proximal to retrocalcaneal bursa)
- Magnetic resonance imaging findings consistent with tendinosis
- Subject (or guardian) must sign IRB approved informed consent form
Key exclusion criteria (11 listed)
- Use of NSAID's (e.g., ibuprofen, naproxen) within 2 weeks prior to treatment by this study
- Previous Achilles surgery on pathology to be treated by this study
- Heel pain associated with plantar fasciosis
- Multiple anatomic origins of pain in foot to be treated by study
- History or documentation showing Type I and Type II Diabetes Mellitus
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 |
|---|---|---|
| plasma microdebriderAlso: TOPAZ MicroDebriderCoblation of the Achilles | Device | A |
| Mechanical Surgical DebridementSurgical Debridement of the Achilles | Procedure or surgery | B |
Primary outcome
To determine whether patients treated using plasma microtenotomy demonstrate equivalent longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores through 12 months postoperatively to patients treated using standard surgical debridement.
Time frame: 12 months
1 secondary outcome
To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- Related InfoLink provided by the sponsor.
Related trials for Achilles Pain
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Tendinopathy, Insertional Achilles Tendinopathy
Not yet recruiting
Achilles Tendinopathy; the Effect of Shockwave Treatment
Achilles Tendinopathy (AT), Achilles Tendon
Recruiting
Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
Acute Achilles Tendon Rupture
Recruiting
Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders
Achilles Tendinopathy (AT), Achilles Tendon Rupture
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.
Terry Philbin, D.O. principal investigator
Orthopedic Foot and Ankle Center, Columbus, OH
2 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 plasma microdebrider and Mechanical Surgical Debridement in people with Achilles Pain and Achilles Tendinosis, run by ArthroCare Corporation at 2 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine whether patients treated using plasma microtenotomy demonstrate equivalent longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores through 12 months postoperatively to patients treated using standard surgical debridement. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2013.