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Protocol halted due to less than anticipated recruitment.
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Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clarix™1k graft | Experimental | Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. |
|
| Control arm without Clarix™1k graft | No Intervention | Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarix™1k graft | Biological | Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score | Baseline,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory C Berlet, MD | Orthopedic Foot and Ankle Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Foot and Ankle Center | Westerville | Ohio | 43082 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clarix™1k Graft | Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue. |
| FG001 | Control Arm Without Clarix™1k Graft | Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clarix™1k Graft | Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue. |
| BG001 | Control Arm Without Clarix™1k Graft | Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score | Posted | Number | units on a scale | Baseline,12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clarix™1k Graft | Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes Zoster | Skin and subcutaneous tissue disorders |
Early termination leading to only one subject completing the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Berlet, MD | Orthopedic Foot and Ankle Center | 614-895-8747 | ofacresearch@orthofootankle.com |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue. |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Control Arm Without Clarix™1k Graft | Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue. | 0 | 1 | 0 | 1 |
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