Achilles TendinopathyPhase 4NCT01341509
A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
A Phase 4 study testing Flexor Hallucis Longus Tendon transfer, Transfer of the Flexor Hallucis Longus Tendon and No transfer of Flexor Hallucis Longus tendon in people with Achilles Tendinopathy, run by OAD Orthopaedics at 1 site in United States.
Trial summary
The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Flexor Hallucis Longus Tendon transfer, Transfer of the Flexor Hallucis Longus Tendon and No transfer of Flexor Hallucis Longus tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female 18 years or older
- Diagnosed with insertional Achilles tendinosis by history and physical exam
- Confirmed by x-ray and MRI
- Calcification at the Achilles insertion and gastrocnemius tightness.
- Failure of the following non-operative treatment for greater than 6 months: *shoe modifications
- physical therapy
Show all 9Show fewer
- immobilization
- and home exercise program.
- In addition, participant must have an intact flexor hallucis longus tendon.
Who cannot join
- Patients who have failed surgery for the same and patients with diabetic neuropathy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OAD Orthopaedics
Warrenville, Illinois, 60555
Marjorie L Delaney, APN, 630-225-2554, marjorie.delaney@oadortho.com
Gregory P Witkowski, MD, 630-225-2663, gregory.witkowski@oadortho.com
About this study
Official title: Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.
- Conditions
- Achilles Tendinopathy
- Being tested
- Flexor Hallucis Longus Tendon transfer, Transfer of the Flexor Hallucis Longus Tendon, No transfer of Flexor Hallucis Longus tendon
- Keywords
- Surgical Treatment of Insertional Achilles Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexor Hallucis Longus Tendon transferProcedure or surgery
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
Transfer of the Flexor Hallucis Longus TendonProcedure or surgery
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
No transfer of Flexor Hallucis Longus tendonProcedure or surgery
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| FHL tendon transferred | Active comparator | Surgical group in which the FHL tendon was transferred Receives: Procedure: Transfer of the Flexor Hallucis Longus Tendon |
| FHL tendon not transferred | Active comparator | Not described Receives: Procedure: Flexor Hallucis Longus Tendon transfer; Procedure: No transfer of Flexor Hallucis Longus tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical difference
To detect a 20% difference in clinical outcomes between the two surgical groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OAD Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory P Witkowski, MD, Principal investigator, OAD Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341509
- Sponsor's protocol ID
- GW100
- Status last verified
- Jun 2013
- First submitted
- 22 Apr 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
- ClinicalTrials.gov ID
- NCT01341509
- Acronym / sponsor ID
- GW100
- Conditions
- Achilles Tendinopathy
- Keywords
- Surgical Treatment of Insertional Achilles Tendinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OAD OrthopaedicsUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (estimated)
- First posted
- 25 Apr 2011 (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 optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FHL tendon transferred | Active comparator | Procedure: Transfer of the Flexor Hallucis Longus TendonSurgical group in which the FHL tendon was transferred |
| FHL tendon not transferred | Active comparator | Procedure: Flexor Hallucis Longus Tendon transfer, Procedure: No transfer of Flexor Hallucis Longus tendon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female 18 years or older
- Diagnosed with insertional Achilles tendinosis by history and physical exam
- Confirmed by x-ray and MRI
- Calcification at the Achilles insertion and gastrocnemius tightness.
- Failure of the following non-operative treatment for greater than 6 months: *shoe modifications
Key exclusion criteria (1 listed)
- Patients who have failed surgery for the same and patients with diabetic neuropathy.
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 |
|---|---|---|
| Flexor Hallucis Longus Tendon transferThe flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy | Procedure or surgery | FHL tendon not transferred |
| Transfer of the Flexor Hallucis Longus TendonThe Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy | Procedure or surgery | FHL tendon transferred |
| No transfer of Flexor Hallucis Longus tendonThere was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy | Procedure or surgery | FHL tendon not transferred |
Primary outcome
Statistical difference
Time frame: 2 years
To detect a 20% difference in clinical outcomes between the two surgical groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
Gregory P Witkowski, MD principal investigator
OAD Orthopaedics
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 Flexor Hallucis Longus Tendon transfer, Transfer of the Flexor Hallucis Longus Tendon and No transfer of Flexor Hallucis Longus tendon in people with Achilles Tendinopathy, run by OAD Orthopaedics 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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjorie L Delaney, APN (630-225-2554, marjorie.delaney@oadortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical difference (time frame: 2 years). 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 11 Jun 2013.