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

NCT02367417 | Unknown

• 1 other identifier: RP02
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Revision; Knee Joint; PMCF; Endo-Modell SL

Outcome Measures

Primary Outcomes (1)

• KOOS

  Knee Injury and Osteoarthritis Outcome Score

  1 yr, 3 yrs and 5 yrs

Secondary Outcomes (4)

• Complications

  At each Follow-up, up to 5 years

• Rate of subsequent surgical interventions

  At each Follow-up, up to 5 years

• KSS

  at 3 months, 1 year and 5 years

• Prosthetic Survival Rate

  up to 5 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waldemar Link GmbH & Co. KG: lead

Study Sites (3)

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Medizinische Fakultät Orthopädische Universitätsklinik (KORT)

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

MeSH Terms

Conditions

Osteonecrosis; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Rheumatic Diseases

Study Officials

• Christoph Lohmann, Prof. Dr.

  Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: August 14, 2017
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

DE (3)