(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…
ID
Bron
Aandoening
Isolated patellofemoral osteoarthritis.
Ondersteuning
Deventer Ziekenhuis
Postbus 5001
7400 GC Deventer
THE NETHERLANDS
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
CT-based femoral component rotation expressed in degrees of rotation relative to the transepicondylar axis (where a positive value denotes external rotation).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
(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.
Onderzoeksopzet
(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.
Onderzoeksproduct en/of interventie
Zimmer Gender-Solutions patellofemoral joint replacement.
Publiek
Deventer Ziekenhuis
Postbus 5001
Hans-Peter W. Jonbergen, van
Deventer 7400 GC
The Netherlands
vanjonbergen@dz.nl
Wetenschappelijk
Deventer Ziekenhuis
Postbus 5001
Hans-Peter W. Jonbergen, van
Deventer 7400 GC
The Netherlands
vanjonbergen@dz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) Isolated patellofemoral osteoarthritis;
(2) Informed consent for the surgical procedure;
(3) Signed informed consent for the study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4003 |
NTR-old | NTR4175 |
CCMO | NL42639.075.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON39527 |