NCT00534781

Brief 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 therapy. Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

September 24, 2007

Last Update Submit

July 10, 2013

Conditions

Achilles PainAchilles TendinosisHeel Pain

Keywords

AchillesTendinosisTendinitisAchilles TendinosisAchilles TendinitisCoblationBipolar RadiofrequencySurgical DebridementDebridementHeel PainAchilles Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.

    12 Months

Study Arms (2)

A

EXPERIMENTAL

plasma microtenotomy

Device: plasma microdebrider

B

ACTIVE COMPARATOR

Standard Surgical Debridement

Procedure: Mechanical Surgical Debridement

Interventions

plasma microdebriderDEVICE

Coblation of the Achilles

Also known as: TOPAZ MicroDebrider
A
Mechanical Surgical DebridementPROCEDURE

Surgical Debridement of the Achilles

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Greater Chesapeake Orthopaedic Associates

Baltimore, Maryland, 21218, United States

Location

Orthopaedic Foot and Ankle Center

Columbus, Ohio, 43231, United States

Location

Related Links

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Terry Philbin, D.O.

    Orthopedic Foot and Ankle Center, Columbus, OH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2008

Study Completion

September 1, 2010

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(2)