Performance of MRK, NexGen and LCS <br>Total Knee Prosthesis based on AP Stability Measurement and PROMS<br>

Completed

Conditions: knee stability
10005944

Registration Number: NL-OMON46917

Lead Sponsor: Antonius Ziekenhuis, Sneek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Osteomalacia
* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint:<br /><br>Measurement with Kneelax device will provide comparison in anterior/posterior<br /><br>displacement (laxity) of the replaced joint at 30, 60 and 90 degrees angle.<br /><br>With these measurements the three prosthesis will be compared. This measurement<br /><br>will take place once: 12 months post-op. Kneelax is a validated device for<br /><br>measuring such displacement. Measurement will take place in hospital under<br /><br>supervision of a trained physical therapist.<br /><br>A difference of 2 mm A/P stability is determined as relevant. </p><br>

Secondary Outcome Measures