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The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.
The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.
The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee arthritis | Other | Total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee replacement | Procedure | Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee prosthesis rotational alignment | Rotational (in deg) positioning of femur, tibia and patella prosthesis components. | At time of surgery |
| Knee prosthesis translational alignment | Translational (in mm) positioning of femur, tibia and patella prosthesis components. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative knee joint rotations | Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt. | At time of surgery |
| Intra-operative knee joint translations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Ensini, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9117525 | Background | Cutbill JW, Ladly KO, Bray RC, Thorne P, Verhoef M. Anterior knee pain: a review. Clin J Sport Med. 1997 Jan;7(1):40-5. doi: 10.1097/00042752-199701000-00008. | |
| 12931800 | Background | Sparmann M, Wolke B, Czupalla H, Banzer D, Zink A. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 16, 2012 | Feb 15, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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open label
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Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations. |
| At time of surgery |
| Post-operative knee joint rotations | Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt. | 24 months |
| Post-operative knee joint translations | Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations. | 24 months |
| 17431587 | Background | Belvedere C, Catani F, Ensini A, Moctezuma de la Barrera JL, Leardini A. Patellar tracking during total knee arthroplasty: an in vitro feasibility study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):985-93. doi: 10.1007/s00167-007-0320-1. Epub 2007 Apr 13. |
| 15534514 | Background | Burnett RS, Haydon CM, Rorabeck CH, Bourne RB. Patella resurfacing versus nonresurfacing in total knee arthroplasty: results of a randomized controlled clinical trial at a minimum of 10 years' followup. Clin Orthop Relat Res. 2004 Nov;(428):12-25. |
| 12770636 | Background | Fantozzi S, Benedetti MG, Leardini A, Banks SA, Cappello A, Assirelli D, Catani F. Fluoroscopic and gait analysis of the functional performance in stair ascent of two total knee replacement designs. Gait Posture. 2003 Jun;17(3):225-34. doi: 10.1016/s0966-6362(02)00096-6. |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |