Completed

NCT Number: NCT00950053

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

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).

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Key information

Conditions

Chronic Insertional Achilles Tendonitis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Achilles decompression & debridement

Procedure

Surgical intervention

Achilles decompression and debridement with FHL transfer

Procedure

surgical intervention

Primary outcomes

ankle plantar flexion strength measured using a handheld dynamometer

Time frame: pre-operatively, 3 months, 6 months, and 1 year

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jul 31, 2009
Registry last updated: Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.