Ankle Arthritis
Conditions
Brief summary
To compare the outcomes of patients who undergo three different types of surgeries for ankle fusion and reconstruction.
Detailed description
It is understood that an elevated concentration of platelets in the mix of the arthrodesis construct applied intra-operatively to the bony surface, has osteo-generating and enhanced wound healing properties. With that knowledge there is a clinical need and enthusiasm for the application of concentrated platelets, which release a large quantity of growth factors to encourage recovery in non healing injuries or surgical sites. This study represents an effort to more clearly define the true clinical outcomes with or without biologic enhancement, and fulfills a need for fortifying evidence concerning the efficacy of ACP in live human bone healing-- based on radiographic and CT scans.
Interventions
BIOLOGICALAutologous Concentrated Plasma
Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use.
Sponsors
Columbia Orthopaedic Group, LLP
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients whom present the need for the elective surgery
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT Scan for Fusion Analysis | 8 weeks post op. | There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fusion+ACP+Autograft Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h | 6 |
| Fusion + ACP +DBM Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use. | 4 |
| Standard-Fusion +Autograft Only Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced. | 0 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death of PI | 6 | 4 | 0 |
Baseline characteristics
| Characteristic | Fusion+ACP+Autograft | Fusion + ACP +DBM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 4 participants | 0 participants | 4 participants |
| Age, Categorical Between 18 and 65 years | 2 participants | 4 participants | 6 participants |
| Gender Female | 3 participants | 4 participants | 7 participants |
| Gender Male | 3 participants | 0 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 4 | 0 / 0 |
Outcome results
Primary
CT Scan for Fusion Analysis
There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.
Time frame: 8 weeks post op.