Clinical trial NCT02288117: Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
Official title: Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Hip
Femur Head Necrosis
Femoral Neck Fractures
Keywords: PMCF
Post Market Clinical Follow up
SP-CL
anatomic stem
Lead sponsor: Waldemar Link GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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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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.

Eligibility criteria: 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

Primary outcomes:
measure: Stem Survival Rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Complication Rate
timeFrame: Up to 5 years
measure: Reoperation Rate
timeFrame: Up to 5 years
measure: Harris Hip Score (HHS)
timeFrame: Up to 5 years
measure: Oxford Hip Score (OHS)
timeFrame: Up to 5 years
measure: Forgotten Joint Score (FJS)
timeFrame: Up to 2 years
measure: Mid Thigh Pain
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
state: Bayern
city: Hamburg
country: Germany
facility: HELIOS ENDO-Klinik
city: Milan
country: Italy
facility: L'Istituto Ortopedico Gaetano Pini
city: Barcelona
country: Spain
facility: Hospital Sant Rafael
Study officials:
affiliation: HELIOS Endo-Klinik Hamburg
name: Thorsten Gehrke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: