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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial

Brief Summary:

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).


Detailed Summary:
Sponsor: OrthoCarolina Research Institute, Inc.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: OrthoCarolina Research Institute, Inc.

Dates:
Date Received: July 29, 2009
Date Started: December 2008
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013