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

• Conditions: Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis

• Registration Number: NCT02288117
• Lead Sponsor: Waldemar Link GmbH & Co. KG

Brief Summary

The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions.

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

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.

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Study Start: 2015-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19
• Primary Completion: 2022-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.
• Patient signed Informed Consent.

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stem Survival Rate	Up to 5 years	The survival of the stem

Secondary Outcome Measures

Name	Time	Method
Complication Rate	Up to 5 years	Number and kind of complications
Reoperation Rate	Up to 5 years	number of reoperations
Harris Hip Score (HHS)	Up to 5 years	Clinical Score to get information about the subjects pain and hip function, collected continuously
Oxford Hip Score (OHS)	Up to 5 years	PROM to assess function and pain after THR
Forgotten Joint Score (FJS)	Up to 2 years	awareness of the artificial joint
Mid Thigh Pain	Up to 5 years	Pain occuring in the front and mid part of the femur

Trial Locations

Locations (4)

Krankenhaus Barmherzige Brüder Regensburg; 🇩🇪 Regensburg, Bayern, Germany

HELIOS ENDO-Klinik; 🇩🇪 Hamburg, Germany

L'Istituto Ortopedico Gaetano Pini; 🇮🇹 Milan, Italy

Hospital Sant Rafael; 🇪🇸 Barcelona, Spain