NANOS Neck Preserving Hip Stem

NCT04036279 | Terminated

• 1 other identifier: R11014-1
• Study Type: observational
• Target: 130
• Locations: 3 countries
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Long term survivorship of Nanos

  Revision for any reason. Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants

  10 years

Other Outcomes (6)

• Intra- and peri-operative device-related adverse events (AE) and complications up to discharge

  10 years

• Postoperative AE up to 10 years

  10 years

• Evaluation of function, range of motion and pain assessed by Harris Hip Score

  10 years

Interventions

Total Hip Arthroplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinic for Orthopedics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (3)

University Marburg, Orthopedics and Rheumatology

Marburg, 35043, Germany

Location

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Samodzielny Publiczny Wojewodzki Spital

Piekary Śląskie, 41-940, Poland

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Turgay Efe, Dr.med

  Phillips University Marburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: January 21, 2010
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1); PL (1)