Spine Fusion, Spine Surgery
Conditions
Brief summary
Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial.
Detailed description
Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts
Interventions
PROCEDUREAnterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft
Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft
PROCEDUREAnterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft
Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients 18 years of age or older * preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.
Exclusion criteria
* patients undergoing a revision cervical procedure * current smokers * patient with surgical indications of tumor, infection, or trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved participant reported outcome measures (PROMs)-1 | 2 years | Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery |
| Improved participant reported outcome measures (PROMs)-2 | 2 years | Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery |
| Improved participant reported outcome measures (PROMs)-3 | 2 years | Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery |
| Fusion status after surgery | 2 years | Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery |
Countries
United States
Outcome results
None listed