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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Hip Femur Head Necrosis Femoral Neck Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No