Arthritis/Arthrosis, Bone Necrosis, Failure of Prosthetic Joint Implant
Conditions
Keywords
Revision, Knee Joint, PMCF, Endo-Modell SL
Brief summary
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
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.
Interventions
None listed
Sponsors
Waldemar Link GmbH & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS | 1 yr, 3 yrs and 5 yrs | Knee Injury and Osteoarthritis Outcome Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | At each Follow-up, up to 5 years | Rate of implant related, surgery related and systemic complications |
| Rate of subsequent surgical interventions | At each Follow-up, up to 5 years | Different surgical interventions |
| KSS | at 3 months, 1 year and 5 years | Knee Society Score to assess knee pain and functional knee capacity |
| Prosthetic Survival Rate | up to 5 years | Survival of the Prosthesis |
Countries
Germany
Outcome results
None listed