NANOS Neck Preserving Hip 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

TERMINATED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-21

Study Completion Date

2023-03-31

Brief Summary

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The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship

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Detailed Description

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The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem.

Effectiveness Measures:

* Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score \[4-6\], UCLA Activity Rating \[7\]
* Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

* Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
* Postoperative AE up to 10 years

Conditions

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Primary Osteoarthritis Secondary Osteoarthritis Dysplasia Osteoarthritis Avascular Femoral Neck Necrosis Post-Traumatic Femoral Neck Necrosis Intact Femoral Neck With Good Bone Quality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Total Hip Arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if \>3 months after the first THR
* Patient agreed to participate in the MCO study by signing the Informed Consent form.
* Age of patient at date of surgery 18 to 65 years
* Patient is likely to comply with study follow-up requirements

Exclusion Criteria

* Previously failed endoprosthesis and /or THR components in relevant hip
* Patient has proven osteoporosis
* Pronounced coxa valga with a femoral neck angle \> 145º
* Pronounced coxa vara with a femoral neck angle \< 125º
* History of infection in the affected joint; systemic infections
* Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated
* Spinal disease with neurologic movement disorders
* Alcoholism or addictive disorders
* ASA score is 3 or 4
* Body mass index (BMI) \> 30
* Patient is pregnant or being pregnant during follow up intervals
* Patients understanding of the language is insufficient for understanding the Patient Information and Consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No