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

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.

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.

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