Suspended

Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Arthritis+16

+ Bone Diseases

+ Femoral Fractures

From 18 to 75 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: July 2015

See protocol details

Summary

Principal SponsorWaldemar Link GmbH & Co. KG

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2015

Actual date on which the first participant was enrolled.

Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions \[2,3\]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.

Official TitleProspective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

NCT02288117

Principal SponsorWaldemar Link GmbH & Co. KG

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesFemoral FracturesFemoral Neck FracturesFemur Head NecrosisHip FracturesJoint DiseasesLeg InjuriesMusculoskeletal DiseasesNecrosisOsteoarthritisOsteonecrosisPathologic ProcessesRheumatic DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesOsteoarthritis, HipHip InjuriesFractures, Bone

Criteria

5 inclusion criteria required to participate

Skeletally mature

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.

Show More Criteria

14 exclusion criteria prevent from participating

Body Mass Index (BMI) > 40 kg/m2

Poor general state of health

Acute and chronic infections, local and systemic

Pharmaceutical or other drug abuse, alcoholism

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, GermanyOpen Krankenhaus Barmherzige Brüder Regensburg in Google Maps

Suspended

HELIOS ENDO-Klinik

Hamburg, Germany

Suspended

L'Istituto Ortopedico Gaetano Pini

Milan, Italy

Suspended

Hospital Sant Rafael

Barcelona, Spain

Suspended4 Study Centers