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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Necrosis; Arthritis/Arthrosis; Failure of Prosthetic Joint Implant

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13589
    • Evangelisches Waldkrankenhaus Spandau
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Medizinische Fakultät Orthopädische Universitätsklinik (KORT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Waldemar Link GmbH & Co. KG
• Investigators: Principal Investigator: Christoph Lohmann, Prof. Dr., Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Revision; Knee Joint; PMCF; Endo-Modell SL
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Osteoarthritis; Necrosis; Osteonecrosis
• Other Study ID Numbers: RP02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No