Clinical trial NCT03086512: A Study Comparing Computerized Tomographic Progression of Bone Bridging After Subtalar Fusion Using Fully and Partially Threaded Screws
Official title: A Randomized Prospective Pivotal Study Comparing Computerized Tomographic Progression of Bone Bridging After Subtalar Fusion Using Fully and Partially Threaded Screws
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subtalar Fusion
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Acumed, LLC
First posted: 2017-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups. Group I consists of 45 patients receiving a subtalar fusion with fully threaded screws (Acutrak 2® - 7.5). Group II consists of 45 patients receiving a subtalar fusion with partially threaded screws (Synthes® 7.3 Cannulated Screw).
Primary purpose: TREATMENT

Brief summary: The study was designed by the principal investigator, Dr. Alastair Younger, and the St. Paul's Hospital Foot and Ankle Research Group, who will conduct the study. The study is being funded by Acumed LLC, the manufacturer of the Health Canada approved Acutrak 2® - 7.5 fully threaded screw.

The purpose of this study is to assess and compare the effectiveness of fully threaded screws versus partially threaded screws in subtalar fusion, in order to determine the effect of the thread configuration on the success of the fusion procedure.

Efficacy will be assessed primarily by computed tomography (CT) analysis of percent bone bridging across the subtalar joint at both 12 and 24 weeks post-op. Outcome scores will also be administered to compare general health and foot function between the two groups at baseline and at multiple post-op follow-up visits. Additional resource utilization (i.e. additional clinic and/or hospital admissions) will also be compared between the two groups post-op.


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

Primary outcomes:
measure: Post-operative CT Scans: 12 Week Width of Joint
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 12 Week Width of Bone Bridging
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 12 Week Width of Any Fixation Hardware
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Width of Joint
timeFrame: Measurements will be assessed at 24 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Width of Bone Bridging
timeFrame: Measurements will be assessed at 24 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Width of Any Fixation Hardware
timeFrame: Measurements will be assessed at 24 weeks post-operation.
measure: Post-operative CT Scans: 12 Week Bone Bridging
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Bone Bridging
timeFrame: Measurements will be assessed at 24 weeks post-operation.
measure: Post-operative CT Scans: 12 Week Group Average Comparisons
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Group Average Comparisons
timeFrame: Measurements will be assessed at 24 weeks post-operation.
measure: Post-operative CT Scans: 12 Week Inter- and Intra Observer Reliability
timeFrame: Measurements will be assessed at 12 weeks post-operation.
measure: Post-operative CT Scans: 24 Week Inter- and Intra Observer Reliability
timeFrame: Measurements will be assessed at 24 weeks post-operation.
Secondary outcomes:
measure: Ankle Osteoarthritis Scale (AOS)
timeFrame: 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.
measure: Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) including Short Form 36 Health Survey (SF-36)
timeFrame: 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.
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 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.
measure: Radiographic assessments performed pre-operatively and post-operatively
timeFrame: There are 4 assessments time points: within 30 days of surgery, 6 weeks post-op, 12 weeks post-op, and 52 weeks post-op.
measure: Resource utilization between the groups including extra clinic visits, any reoperations within the study period, and any additional days in hospital during the study period
timeFrame: Outcome will be measured through study completion, an average of 1 year post-operation per patient.
measure: Relationship between disease specific outcome scores (AOS and FAAM) and degree of bone bridging
timeFrame: Outcome will be measured after AOS/FAAM outcome scores and degree of bone bridging is assessed for each patient, at approximately 1 year post-operation. .
measure: Inter and intra observer reliability of the percent bone healing measured on sagittal and coronal views
timeFrame: Measurements will be assessed at same time points as CT scans, at 12 and 24 weeks post-operation.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
References: