A Study Comparing Computerized Tomographic Progression of... | NCT03086512

Status Module

Name	Class
Acumed, LLC	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Active Comparator	Group I consists of 45 patients receiving a subtalar fusion with the Acutrak 2® - Fully Threaded Screw.	Device: Acutrak 2® - 7.5 Screw
Group II	Sham Comparator	Group II consists of 45 patients receiving a subtalar fusion with the Partially Threaded Synthes® 7.3 Cannulated Screw.	Device: Synthes® 7.3 Cannulated Screw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acutrak 2® - 7.5 Screw	Device	The Acumed Acutrak 2® - 7.5 is a fully-threaded headless screw fixation, composed of 17 unique screw size options. The Acutrak 2® - 7.5 is available in sizes from 40 mm to 120 mm and is inserted using a 4.0 mm hex driver over a .094" guide wire. The Acutrak 2 Part Number is 30-0XXX and 30-0XXX-S.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative CT Scans: 12 Week Width of Joint	This outcome measure is to compare bone bridging between full thread versus partial thread screw. The coronal images will have the area of the screw masked and will be reviewed by three independent, trained, and blinded observers. For each observer at the time-point, each slice of the CT scan will be reviewed and the width of the joint will be measured.	Measurements will be assessed at 12 weeks post-operation.
Post-operative CT Scans: 12 Week Width of Bone Bridging	This outcome measure is to compare bone bridging between full thread versus partial thread screw. The coronal images will have the area of the screw masked and will be reviewed by three independent, trained, and blinded observers. For each observer at the time-point, each slice of the CT scan will be reviewed and the width of bone bridging will be measured.	Measurements will be assessed at 12 weeks post-operation.
Post-operative CT Scans: 12 Week Width of Any Fixation Hardware	This outcome measure is to compare bone bridging between full thread versus partial thread screw. The coronal images will have the area of the screw masked and will be reviewed by three independent, trained, and blinded observers. For each observer at the time-point, each slice of the CT scan will be reviewed and the width of any fixation hardware will be measured.	Measurements will be assessed at 12 weeks post-operation.
Post-operative CT Scans: 24 Week Width of Joint	This outcome measure is to compare bone bridging between full thread versus partial thread screw. The coronal images will have the area of the screw masked and will be reviewed by three independent, trained, and blinded observers. For each observer at the time-point, each slice of the CT scan will be reviewed and the width of the joint will be measured.	Measurements will be assessed at 24 weeks post-operation.

Secondary Outcomes

Measure	Description	Time Frame
Ankle Osteoarthritis Scale (AOS)	This questionnaire assesses pain and difficulty in both the left and right ankle.	Outcome will be administered 5 times per patient: within 30 days of surgery, 6 weeks post-op, 12 weeks post-op, 24 weeks post-op and 52 weeks post-op.
Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) including Short Form 36 Health Survey (SF-36)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is at least 19 years of age.
The subject is considered to be skeletally mature.
The subject qualifies for subtalar fusion based on physical examination and/ or past medical history including isolated osteoarthritis, post-traumatic, degenerative, or rheumatoid arthritis of the ankle.
The subject experiences severe pain in the subtalar joint that could not be cured with non-operative treatment options.
The patient may undergo a subtalar fusion as part of a triple arthrodesis.
The patient has a normally functioning ankle joint, a solidly fused ankle joint, or a well-functioning ankle joint replacement.
The patient may have forefoot pathology addressed by either prior or concurrent surgery (osteotomies or fusions).
An ankle joint replacement or ankle joint fusion may be performed during the same sitting.
The patient consented for either an arthroscopic or open procedure.
The subject is able to comply with all post-operative evaluations and visits.
The subject consents to and will receive either a cancellous autograft bone graft or synthetic bone graft substitute

Exclusion Criteria:

The subject has:
1. Severe osteoporosis
2. Neuromuscular impairment
3. Prior infection in the affected joint
The subject currently has acute infections that, in the opinion of the Investigator, may complicate healing.
The subject has a known sensitivity or allergic reaction to the screw material.
The subject has insufficient bone stock or bone quality to support the screws.
The subject has a major risk factor for non-union (ex. poorly controlled diabetes or current smoker).
The subject is undergoing a revision of a prior subtalar fusion.
The subject has a BMI of > 50 kg/m2.
The subject is known to be pregnant, or plans to become pregnant during the study period
The investigator judges the subject to be unable or unlikely to remain compliant to follow-up due to a physical or mental condition (ex. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.).
The subject is unable to provide informed consent.
The subject is unable to communicate with the research team.
The subject is unable to comply with follow-up.
The subject has a history of substance addiction (e.g. recreational drugs, narcotics, or alcohol) within 12 months prior to screening for study entry
The subject is a prisoner, or is known or suspected to be transient
The subject either does not consent to or will not be receiving either a cancellous autograft bone graft or synthetic bone graft substitute
The subject will be receiving a structural autograft or allograft (such as a femoral head graft or tri cortical iliac crest graft) to fill a defect greater than 1cm3