Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
NCT ID: NCT02288117
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
240 participants
OBSERVATIONAL
2015-07-31
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject agrees to comply with the required postoperative management and follow-up evaluations
* Undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment
* Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
* Patient signed Informed Consent.
Exclusion Criteria
* Poor general state of health
* Acute and chronic infections, local and systemic
* Pharmaceutical or other drug abuse, alcoholism
* Allergies to implant materials
* Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
* Insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis
* Severe osteoporosis
* Foreseeable overload/ overstressing of the joint prosthesis
* Acetabular defects
* Female patient who is pregnant or plans to became pregnant during the course of the study
* 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
* Patient who has not signed the Informed Consent
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Waldemar Link GmbH & Co. KG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thorsten Gehrke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
HELIOS Endo-Klinik Hamburg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, Germany
HELIOS ENDO-Klinik
Hamburg, , Germany
L'Istituto Ortopedico Gaetano Pini
Milan, , Italy
Hospital Sant Rafael
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1202 HP
Identifier Type: -
Identifier Source: org_study_id