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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00950053
First received: July 29, 2009
Last updated: March 11, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Visual analog pain scale (VAS) [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Hallux plantarflexion strength using the dynamometer [ Time Frame: pre-operatively, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Surgical complications [ Time Frame: Date of Surgery ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00950053     History of Changes
Other Study ID Numbers: 120808A
Study First Received: July 29, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014