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

July 29, 2009
March 11, 2013
December 2008
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00950053 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Insertional Achilles Tendonitis
  • Procedure: Achilles decompression & debridement
    Surgical intervention
  • Procedure: Achilles decompression and debridement with FHL transfer
    surgical intervention
  • Active Comparator: Achilles decompression & debridement
    Intervention: Procedure: Achilles decompression & debridement
  • 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).
    Intervention: Procedure: Achilles decompression and debridement with FHL transfer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00950053
120808A
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Principal Investigator: Bruce E Cohen, MD OrthoCarolina, P.A.
OrthoCarolina Research Institute, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP