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Performance of MRK, NexGen and LCS Total Knee Prosthesis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28301
Enrollment
240
Registered
2018-02-21
Start date
2015-12-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee arthroplasty stability mrk proms

Interventions

N.A.

Sponsors

Antonius hospital Sneek Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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 • 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

Design outcomes

Primary

MeasureTime frame
Measurement AP stability 12 months post-op with Kneelax device

Contacts

Public ContactRichard Haan, de
rdehaan@bdhmedical.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)