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

Bone Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02367417
• Other study ID #: RP02
• Status: Active, not recruiting
• Start date: August 14, 2017
• Est. completion date: September 2025

Study information

• Verified date: January 2023
• Source: Waldemar Link GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis/Arthrosis
• Bone Necrosis
• Failure of Prosthetic Joint Implant
• Necrosis
• Osteoarthritis
• Osteonecrosis

Locations

Country	Name	City	State
Germany	Evangelisches Waldkrankenhaus Spandau	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Medizinische Fakultät Orthopädische Universitätsklinik (KORT)	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Waldemar Link GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS	Knee Injury and Osteoarthritis Outcome Score	1 yr, 3 yrs and 5 yrs
Secondary	Complications	Rate of implant related, surgery related and systemic complications	At each Follow-up, up to 5 years
Secondary	Rate of subsequent surgical interventions	Different surgical interventions	At each Follow-up, up to 5 years
Secondary	KSS	Knee Society Score to assess knee pain and functional knee capacity	at 3 months, 1 year and 5 years
Secondary	Prosthetic Survival Rate	Survival of the Prosthesis	up to 5 years