Bone NecrosisNCT02367417
Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®
An observational study of Bone Necrosis and Arthritis/Arthrosis, run by Waldemar Link GmbH & Co. KG at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Necrosis, Arthritis/Arthrosis, Failure of Prosthetic Joint Implant
- How many people
- 61 participants
- Where
- 3 sitesGermany
- Study dates
- 14 Aug 2017to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Evangelisches Waldkrankenhaus Spandau
Berlin, 13589
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Medizinische Fakultät Orthopädische Universitätsklinik (KORT)
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: 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.
Read the 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.
- Keywords
- Revision, Knee Joint, PMCF, Endo-Modell SL
- Medical subject headings
- Osteonecrosis, Arthritis, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
Knee Injury and Osteoarthritis Outcome Score
Measured: 1 yr, 3 yrs and 5 yrs
Secondary outcomes (4)
Complications
Rate of implant related, surgery related and systemic complications
Measured: At each Follow-up, up to 5 years
Rate of subsequent surgical interventions
Different surgical interventions
Measured: At each Follow-up, up to 5 years
KSS
Knee Society Score to assess knee pain and functional knee capacity
Measured: at 3 months, 1 year and 5 years
Prosthetic Survival Rate
Survival of the Prosthesis
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start14 Aug 2017
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldemar Link GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Lohmann, Prof. Dr., Principal investigator, Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367417
- Sponsor's protocol ID
- RP02
- Status last verified
- Jan 2023
- First submitted
- 12 Feb 2015
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL® Rotational and Hinge Knee Prosthesis
- ClinicalTrials.gov ID
- NCT02367417
- Acronym / sponsor ID
- RP02
- Keywords
- Revision, Knee Joint, PMCF, Endo-Modell SL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Waldemar Link GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KOOS
Time frame: 1 yr, 3 yrs and 5 yrs
Knee Injury and Osteoarthritis Outcome Score
4 secondary outcomes
Complications
Time frame: At each Follow-up, up to 5 years
Rate of subsequent surgical interventions
Time frame: At each Follow-up, up to 5 years
KSS
Time frame: at 3 months, 1 year and 5 years
Prosthetic Survival Rate
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Lohmann, Prof. Dr. principal investigator
Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Necrosis and Arthritis/Arthrosis, run by Waldemar Link GmbH & Co. KG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS (time frame: 1 yr, 3 yrs and 5 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.