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
  Purpose

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.


Condition Intervention Phase
Achilles Pain
Achilles Tendinosis
Heel Pain
Device: plasma microdebrider
Procedure: Mechanical Surgical Debridement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"

Resource links provided by NLM:


Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: September 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
plasma microtenotomy
Device: plasma microdebrider
Coblation of the Achilles
Other Name: TOPAZ MicroDebrider
Active Comparator: B
Standard Surgical Debridement
Procedure: Mechanical Surgical Debridement
Surgical Debridement of the Achilles

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534781

Locations
United States, Maryland
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, United States, 21218
United States, Ohio
Orthopaedic Foot and Ankle Center
Columbus, Ohio, United States, 43231
Sponsors and Collaborators
ArthroCare Corporation
Investigators
Principal Investigator: Terry Philbin, D.O. Orthopedic Foot and Ankle Center, Columbus, OH
  More Information

Additional Information:
No publications provided

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00534781     History of Changes
Other Study ID Numbers: SM-107WW
Study First Received: September 24, 2007
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:
Achilles
Tendinosis
Tendinitis
Achilles Tendinosis
Achilles Tendinitis
Coblation
Bipolar Radiofrequency
Surgical Debridement
Debridement
Heel Pain
Achilles Pain

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014