Clinical trial NCT04036279: NANOS Neck Preserving Hip Stem
Official title: A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Dysplasia Osteoarthritis
Avascular Femoral Neck Necrosis
Post-Traumatic Femoral Neck Necrosis
Intact Femoral Neck With Good Bone Quality
Keywords: NANOS
Hip
Neck Preserving Stem
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic for Orthopedics

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Long term survivorship of Nanos
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
measure: Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
timeFrame: 10 years
measure: Postoperative AE up to 10 years
timeFrame: 10 years
measure: Evaluation of function, range of motion and pain assessed by Harris Hip Score
timeFrame: 10 years
measure: Evaluation of function, range of motion and pain as assessed by HOOS score
timeFrame: 10 years
measure: Evaluation of function, range of motion and pain as assessed by UCLA Activity Rating
timeFrame: 10 years
measure: Radiographic changes as defined by resorption, radiolucent lines, osteolysis, hypo- and hypertrophy, implant migration or loosening
timeFrame: 10 years
Locations:
city: Marburg
country: Germany
facility: University Marburg, Orthopedics and Rheumatology
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Piekary Śląskie
country: Poland
facility: Samodzielny Publiczny Wojewodzki Spital
Study officials:
affiliation: Phillips University Marburg, Germany
name: Turgay Efe, Dr.med
role: PRINCIPAL_INVESTIGATOR
References: