Clinical trial NCT02367417: Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®
Official title: Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL® Rotational and Hinge Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Necrosis
Arthritis/Arthrosis
Failure of Prosthetic Joint Implant
Keywords: Revision
Knee Joint
PMCF
Endo-Modell SL
Lead sponsor: Waldemar Link GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects enrolled in the PMCF in compliance with the inclusion/exclusion criteria who signed the Informed Consent Form and received the Endo-Model SL® prosthesis, will be included in the primary and secondary endpoint analysis.

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.

Eligibility 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

Primary outcomes:
measure: KOOS
timeFrame: 1 yr, 3 yrs and 5 yrs
Secondary outcomes:
measure: Complications
timeFrame: At each Follow-up, up to 5 years
measure: Rate of subsequent surgical interventions
timeFrame: At each Follow-up, up to 5 years
measure: KSS
timeFrame: at 3 months, 1 year and 5 years
measure: Prosthetic Survival Rate
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Medizinische Fakultät Orthopädische Universitätsklinik (KORT)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
Study officials:
affiliation: Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg
name: Christoph Lohmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: