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

Waldemar Link (LINK)

Status: Unknown

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02288117

1202 HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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