Chronic Insertional Achilles TendonitisPhase 4NCT00950053
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
A Phase 4 study testing Achilles decompression & debridement and Achilles decompression and debridement with FHL transfer in people with Chronic Insertional Achilles Tendonitis, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Insertional Achilles Tendonitis
- What is being tested?
- Achilles decompression & debridement and Achilles decompression and debridement with FHL transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Chronic Insertional Achilles Tendonitis
- Being tested
- Achilles decompression & debridement, Achilles decompression and debridement with FHL transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles decompression & debridementProcedure or surgery
Surgical intervention
Achilles decompression and debridement with FHL transferProcedure or surgery
surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Achilles decompression & debridement | Active comparator | Not described Receives: Procedure: Achilles decompression & debridement |
| Achilles decompression,debride&FHLtransf | Active comparator | 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). Receives: Procedure: Achilles decompression and debridement with FHL transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
ankle plantar flexion strength measured using a handheld dynamometer
Measured: pre-operatively, 3 months, 6 months, and 1 year
Secondary outcomes (6)
American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score
Measured: pre-operatively, 3 months, 6 months, and 1 year
Visual analog pain scale (VAS)
Measured: pre-operatively, 3 months, 6 months, and 1 year
Hallux plantarflexion strength using the dynamometer
Measured: pre-operatively, 3 months, 6 months, and 1 year
Patient Satisfaction
Measured: 1 year
Surgical complications
Measured: Date of Surgery
Postoperative complications
Measured: 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insertional Achilles TendonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce E Cohen, MD, Principal investigator, OrthoCarolina, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950053
- Sponsor's protocol ID
- 120808A
- Status last verified
- Mar 2013
- First submitted
- 29 Jul 2009
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00950053
- Acronym / sponsor ID
- 120808A
- Conditions
- Chronic Insertional Achilles Tendonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Achilles decompression & debridement | Active comparator | Procedure: Achilles decompression & debridement |
| Achilles decompression,debride&FHLtransf | Active comparator | Procedure: Achilles decompression and debridement with FHL transferAchilles 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Achilles decompression & debridementSurgical intervention | Procedure or surgery | Achilles decompression & debridement |
| Achilles decompression and debridement with FHL transfersurgical intervention | Procedure or surgery | Achilles decompression,debride&FHLtransf |
Primary outcome
ankle plantar flexion strength measured using a handheld dynamometer
Time frame: pre-operatively, 3 months, 6 months, and 1 year
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce E Cohen, MD principal investigator
OrthoCarolina, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Achilles decompression & debridement and Achilles decompression and debridement with FHL transfer in people with Chronic Insertional Achilles Tendonitis, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ankle plantar flexion strength measured using a handheld dynamometer (time frame: pre-operatively, 3 months, 6 months, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.