SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02251535

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Retrospective Non-randomized In-vivo Comparison of Different Levels of Femoral Rollback in the ATTUNE Total Knee Arthroplasiy System on the Basis of Fluoroscopic and Marker-based Motion Capture Evaluation.

Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs. rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based motion capture evaluation. How do different levels of intra-operatively observed femoral rollback correlate to postoperative kinematics under weight bearing conditions? Does the modified design of the Attune Knee System influence the extent of the femoral rollback compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12 months follow up or is it reduced by, for example, remodelling of the posterior cruciate ligament?

NCT02251535 Gonarthrosis
MeSH: Osteoarthritis, Knee
HPO: Knee osteoarthritis

2 Interventions

Name: ATTUNE® Knee System

Type: Device

test group 1 test group 2

Name: PFC® SIGMA® Knee System

Type: Device

control group


Primary Outcomes

Description: We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.

Measure: tibio-femoral anterior-posterior translation

Time: at 12 months post operative

Secondary Outcomes

Description: We intend to collect the following secondary objective data pre operatively and '12 months post operative: - PKIP

Measure: quality of life

Time: at 12 months post operative

Description: We intend to collect the following secondary objective data pre operatively and '12 months post operative: - KOOS

Measure: quality of life

Time: at 12 months post operative

Description: We intend to collect the following secondary objective data pre operatively and '12 months post operative: - WOMAC

Measure: quality of life

Time: at 12 months post operative

Description: We intend to collect the following secondary objective data pre operatively and '12 months post operative: - SF 36

Measure: quality of life

Time: at 12 months post operative

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T20S

Here, we use an infra-red optical motion capture system (10 T20S cameras, Vicon, Oxford, UK; system accuracy \-0.3-0.5 mm), tracked at120Hz, as well as 2 force plates (AMTI 0R6, Watertown, MA, USA) in order to assess the external forces while performing active movements. --- T20S ---



HPO Nodes


HPO:
Knee osteoarthritis
Genes 3
COL2A1 COL9A2 SMAD3