|- candidate number||15421|
|- NTR Number||NTR4175|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-sep-2013|
|- Secondary IDs||NL42639.075.13 |
|- Public Title||Femoral component rotation in patellofemoral joint replacement.|
|- Scientific Title||Femoral component rotation in Zimmer Gender-Solutions patellofemoral joint replacement: relation with clinical outcomes.|
|- hypothesis||(1) When using the lower leg axis as a reference, the CT-based femoral component rotation with Zimmer Gender-Solutions patellofemoral joint replacement is 3 to 6 degrees external relative to the transepicondylar axis.
(2) The short-term (less than 2 years) clinical outcomes of Zimmer patellofemoral joint replacement are related to the actual amount of femoral component rotation.
|- Healt Condition(s) or Problem(s) studied||Isolated medial compartment osteoarthritis (OA)|
|- Inclusion criteria||(1) Isolated patellofemoral osteoarthritis;|
(2) Informed consent for the surgical procedure;
(3) Signed informed consent for the study.
|- Exclusion criteria||(1) Contra-indication for joint replacement surgery in general (pregnancy, active infection, severe cardiac and respiratory comorbidities);|
(2) Previous distal femoral fracture resulting in an altered anatomy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2013|
|- planned closingdate||30-sep-2015|
|- Target number of participants||40|
|- Interventions||Zimmer Gender-Solutions patellofemoral joint replacement.|
|- Primary outcome||CT-based femoral component rotation expressed in degrees of rotation relative to the transepicondylar axis (where a positive value denotes external rotation).|
|- Secondary outcome||Clinical outcomes at 1-year follow-up as assessed with the patient reported KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score).|
|- Timepoints||(1) Preoperative: clinical (KOOS) and radiological assessment, screening, informed consent;|
(2) Patellofemoral joint replacement;
(3) 1-3 days post-surgery: CT assessment of femoral component rotation;
(4) 1 year post-surgery: clinical (KOOS) and radiological assessment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD Hans-Peter W. Jonbergen, van|
|- CONTACT for SCIENTIFIC QUERIES||MD Hans-Peter W. Jonbergen, van|
|- Sponsor/Initiator ||Deventer Ziekenhuis, Department of Orthopaedic Surgery|
(Source(s) of Monetary or Material Support)
|- Brief summary||Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. The short and mid-term outcomes are related to malposition and unexplained pain.
The ‘Zimmer Gender-Solutions Patello-Femoral Joint (PFJ) System’ is a third generation, asymmetrical patellofemoral joint prosthesis. The surgical technique is highly reproducible although assessment of correct rotational alignment remains difficult. The ‘Surgical Technique’ brochure suggests using Whiteside’s line or the transepicondylar axis. In practice the lower leg axis as described by Clark et al. is used (Clark et al. 2012).
At present, no studies have been performed that demonstrate the actual amount of rotation achieved with the Zimmer prosthesis or other prosthetic designs. Considering the importance of avoiding malposition, further study is needed.
We hypothesize that the CT-based (actual) femoral component rotation is 3 to 6 degrees external relative to the transepicondylar axis. Furthermore, we hypothesize that the short-term (less than 2 years) clinical outcomes of the Zimmer patellofemoral prosthesis are related to the actual amount of femoral component rotation.|
|- Main changes (audit trail)|
|- RECORD||22-sep-2013 - 2-okt-2013|