Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT00534781
First received: September 24, 2007
Last updated: July 10, 2013
Last verified: July 2013

September 24, 2007
July 10, 2013
September 2007
July 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00534781 on ClinicalTrials.gov Archive Site
To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups. [ Time Frame: 12 Months ]
Not Provided
Not Provided
 
Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Achilles Pain
  • Achilles Tendinosis
  • Heel Pain
  • Device: plasma microdebrider
    Coblation of the Achilles
    Other Name: TOPAZ MicroDebrider
  • Procedure: Mechanical Surgical Debridement
    Surgical Debridement of the Achilles
  • Experimental: A
    plasma microtenotomy
    Intervention: Device: plasma microdebrider
  • Active Comparator: B
    Standard Surgical Debridement
    Intervention: Procedure: Mechanical Surgical Debridement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00534781
SM-107WW
No
ArthroCare Corporation
ArthroCare Corporation
Not Provided
Principal Investigator: Terry Philbin, D.O. Orthopedic Foot and Ankle Center, Columbus, OH
ArthroCare Corporation
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP