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Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950053
First Posted: July 31, 2009
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
  Purpose

The purpose of this study is to determine whether Achilles tendon debridement and decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved clinical and functional outcome as measured by ankle plantar flexion strength and American Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression alone in patients over 50 years of age with chronic insertional Achilles tendinosis.

H0: There will be no difference in ankle plantar flexion strength measured using a handheld dynamometer between patients randomized to achilles tendon decompression and debridement alone (Group 1) and patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).

HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will have less ankle plantar flexion strength compared to patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).


Condition Intervention Phase
Chronic Insertional Achilles Tendonitis Procedure: Achilles decompression & debridement Procedure: Achilles decompression and debridement with FHL transfer Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • ankle plantar flexion strength measured using a handheld dynamometer [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ]

Secondary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ]
  • Visual analog pain scale (VAS) [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ]
  • Hallux plantarflexion strength using the dynamometer [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ]
  • Patient Satisfaction [ Time Frame: 1 year ]
  • Surgical complications [ Time Frame: Date of Surgery ]
  • Postoperative complications [ Time Frame: 3 months, 6 months, and 1 year ]

Enrollment: 52
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Achilles decompression & debridement Procedure: Achilles decompression & debridement
Surgical intervention
Active Comparator: Achilles decompression,debride&FHLtransf
Achilles tendon decompression and debridement augmented with FHL transfer. The preferred skin incision will be followed by central-splitting Achilles debridement, resection of a Haglund's lesion if present and pathologic, followed by FHL harvest for patients in group 2. The fixation technique in group 2 will utilize an interference screw for the FHL. For all patients, the Achilles will be reattached with lateral and medial suture anchors (just distal to interference screw in FHL patients).
Procedure: Achilles decompression and debridement with FHL transfer
surgical intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 50 years of age or older
  • Patients diagnosed with chronic insertional Achilles tendonitis
  • Failed greater than 3 months of conservative treatment (activity and shoe modification, heel lifts, non-steroidal anti-inflammatory medications, stretching exercises, and formal physical therapy)

Exclusion Criteria:

  • Patients less than 50 years of age upon presentation
  • Females of child-bearing potential
  • Patients who have a history of ipsilateral Achilles tendon rupture
  • History of infection in the same lower extremity
  • Patients unable to undergo MRI scan
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950053


Locations
United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: Bruce E Cohen, MD OrthoCarolina, P.A.
  More Information

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00950053     History of Changes
Other Study ID Numbers: 120808A
First Submitted: July 29, 2009
First Posted: July 31, 2009
Last Update Posted: March 13, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Tendinopathy
Bursitis
Exostoses
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Joint Diseases
Hyperostosis
Bone Diseases


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