We will be assessing multiple self-reported putative biomarkers, either accessed remotely from an off-site computer (e.g. at home) or at the clinic visits if necessary.
Two measures of physical function will be assessed: the Five Times Sit-to-Stand Test (5TSTS) and the 6-meter Walk Test (6MWT) following standard protocols. In addition to functional capability, pain will be assessed prior to and immediately following each test to assess movement pain. With a brief rest between tests, these assessments should take no more than 15 min.
To assess pain sensitivity, three forms of QST will be performed, requiring approximately 15 min with rest intervals between tests:
Imaging data will be collected using a number of imaging modalities that are acquired using a magnetic resonance scanner. These include:
2 - 6 weeks before surgery
3 - 28 days after surgery
6 weeks after surgery
3 months after surgery
3 months after surgery for selected group
6 months after surgery
12 months after surgery
Set of Surveys: Online after consent, prior to visit or at study visit
Brief Surveys - Remote
Note: Not all study participants will be selected to come in for Visit 3.
Data will be made publicly available upon completion of the project.
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information. A2CPS will submit human sample-derived data to both unrestricted and controlled access databases. All individual-level data will be coded with linked identifiers to controlled-access meta-data labels/tables that will facilitate coordinated identification across samples, individuals, and databases.
In addition, this study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
Data Types & Data Availability
Papers & Protocols