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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02288117
• Other study ID #: 1202 HP
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: May 2023

Study information

• Verified date: December 2020
• Source: Waldemar Link GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: May 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Femur Head Necrosis
• Necrosis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
Germany	HELIOS ENDO-Klinik	Hamburg
Germany	Krankenhaus Barmherzige Brüder Regensburg	Regensburg	Bayern
Italy	L'Istituto Ortopedico Gaetano Pini	Milan
Spain	Hospital Sant Rafael	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Waldemar Link GmbH & Co. KG

Countries where clinical trial is conducted

Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stem Survival Rate	The survival of the stem	Up to 5 years
Secondary	Complication Rate	Number and kind of complications	Up to 5 years
Secondary	Reoperation Rate	number of reoperations	Up to 5 years
Secondary	Harris Hip Score (HHS)	Clinical Score to get information about the subjects pain and hip function, collected continuously	Up to 5 years
Secondary	Oxford Hip Score (OHS)	PROM to assess function and pain after THR	Up to 5 years
Secondary	Forgotten Joint Score (FJS)	awareness of the artificial joint	Up to 2 years
Secondary	Mid Thigh Pain	Pain occuring in the front and mid part of the femur	Up to 5 years