Is there a significant difference in Anterior/Posterior stability between MRK, LCS and NexGen total knee prosthesis 1 year post-op?
ID
Bron
Aandoening
knee arthroplasty stability mrk proms
Ondersteuning
Sneek
Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Measurement AP stability 12 months post-op with Kneelax device
Achtergrond van het onderzoek
This study aims to distinguish relevant differences between three well established types of prosthesis regarding anterior/posterior stability; Medial Rotation Knee, MRK (Matortho, UK), LCS (Depuy, UK, USA) and NexGen (Zimmer, USA). Data derived from the study will give new insight in relevant different behaviour of prosthesis mentioned above and will lead to better understanding of improving patient satisfaction in total knee arthroplasty.
Doel van het onderzoek
Is there a significant difference in Anterior/Posterior stability between MRK, LCS and NexGen total knee prosthesis 1 year post-op?
Onderzoeksopzet
12 months
Onderzoeksproduct en/of interventie
N.A.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients requiring a knee replacement as determined jointly by the surgeon and the patient
• Over 18 years of age at time of surgery
• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
• Patients who are capable of, and have given, informed consent to their participation in the study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients lacking capacity to or who will not provide consent
• Severe muscular, neurological or vascular deficiencies which compromise the affected extremity
• Bone deficiency or deficient bone quality likely to compromise the implant (as determined by surgical team on pre-operative radiographs)
• Severe ligament instability
• Hypersensitivity to the materials used
• Alcoholism or other addictive disorders
• Sepsis
• Osteomyelitis
• Severe Osteoporosis – clinical judgement
• Metabolic disorders which may impair bone formation
• Non correctable flexion contractures >20 degrees
• Varus/valgus deformities >15 degrees
• Those whose prospects for a recovery to independent mobility would be compromised by known pre-existing medical conditions
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6856 |
| NTR-old | NTR7035 |
| Ander register | METC Enschede ID : P14-05 |