Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®

Study Overview
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Brief Summary
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The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.

Detailed Description
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Post Market Clinical Follow-ups (PMCF) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. Against this background a prospective multi-center study with the LINK® Endo-Model® SL® will be conducted.

Official Title
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Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL® Rotational and Hinge Knee Prosthesis

Conditions
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Bone Necrosis, Arthritis/Arthrosis, Failure of Prosthetic Joint Implant

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Implantation of the LINK® Endo-Model® SL®. Between 18 and 78 years of age. Patient has signed the Informed Consent. The indications and contraindications for the implantation of the LINK® Endo-Model® SL® listed in the product catalogue and chapter 2.5 and 2.6 [of the protocol] are applicable and have to be considered / fulfilled Exclusion criteria Body Mass Index (BMI) > 40 kg/m2 Poor general state of health with a foreseeable life expectancy of less than 5 years Knee replacement on the contralateral side within the last year and with a KSS fuctional score < 70 points Comorbidities and known medical circumstances which forseeable affect the clinical functional results after implantation (e.g. neurological or musculoskeletal impairments) Revision in floride septic environment Female patient who is pregnant Prisoner Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 1 yr, 3 yrs and 5 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Rate of implant related, surgery related and systemic complications | At each Follow-up, up to 5 years | 
| Rate of subsequent surgical interventions | Different surgical interventions | At each Follow-up, up to 5 years | 
| KSS | Knee Society Score to assess knee pain and functional knee capacity | at 3 months, 1 year and 5 years | 
| Prosthetic Survival Rate | Survival of the Prosthesis | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision, Knee Joint, PMCF, Endo-Modell SL