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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Femur Head Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures

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 Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22767
    • Helios ENDO-Klinik
  • Bayern
    • Regensburg, Bayern, Germany, 93049
      • Krankenhaus Barmherzige Bruder Regensburg
• Italy
  • Milan, Italy, 1-20122
    • L'Istituto Ortopedico Gaetano Pini
• Spain
  • Barcelona, Spain, 08035
    • Hospital Sant Rafael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with mobility-limiting disease, fracture or defect of the hip joint requiring primary THA with SP-CL® (i.e. primary or secondary coxarthrosis, osteoarthritis, femoral neck fracture, necrosis of the femoral head)

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Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stem Survival Rate	The survival of the stem	Up to 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Waldemar Link GmbH & Co. KG
• Investigators: Principal Investigator: Thorsten Gehrke, Prof. Dr., HELIOS ENDO-Klinik Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: PMCF; Post Market Clinical Follow up; SP-CL; anatomic stem
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteonecrosis; Osteoarthritis; Hip Fractures; Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis
• Other Study ID Numbers: 1202 HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided