Tendon Tears
Conditions
Keywords
Peroneal tendon
Brief summary
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.
Interventions
BIOLOGICALClarix™1k graft
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.
Sponsors
Orthopedic Foot and Ankle Center, Ohio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients requiring surgical repair of the peroneal tendon 2. Patients who voluntarily consent to research participation 3. Patients over the age of 18
Exclusion criteria
1. Patients who display a high surgical risk as determined by the investigative surgeon 2. Previous surgical repair of the peroneal tendon less than 2 years prior to surgery 3. Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion 4. Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B 5. Patients who are pregnant or breast feeding. 6. Patients who have had a clinically diagnosed autoimmune disease 7. Patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative immobilization period 8. Patients with an active infection 9. Patients who have a medical history that would likely make the patient an unreliable research participant 10. Patients requiring surgical repair of the peroneus longus tendon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Baseline,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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clarix™1k Graft Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue. | 1 |
| Control Arm Without Clarix™1k Graft Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue. | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Clarix™1k Graft | Control Arm Without Clarix™1k Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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
Time frame: Baseline,12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | VAS pain at Baseline | 66 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | VAS pain at 12 months | 0 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Change in VAS pain from Baseline to 12 months | -66 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | FFI at Baseline | 61.76 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | FFI at 12 months | 4.71 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Change in FFI from Baseline to 12 months | -57.05 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | AOFAS at Baseline | 70 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | AOFAS at 12 months | 90 units on a scale |
| Clarix™1k Graft | Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Change in AOFAS from Baseline to 12 months | 20 units on a scale |