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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-14

Study Completion Date

2025-09-30

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.

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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.

Conditions

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Bone Necrosis Arthritis/Arthrosis Failure of Prosthetic Joint Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No