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

Waldemar Link (LINK)

Status: Active, not recruiting

Conditions: Bone Necrosis; Failure of Prosthetic Joint Implant; Arthritis/Arthrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02367417

RP02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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