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NANOS Neck Preserving Hip Stem

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Smith & Nephew

Status

Terminated

Conditions

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

Treatments

Procedure: Total Hip Arthroplasty

Study type

Observational

Funder types

Industry

Identifiers

NCT04036279
R11014-1

Details and patient eligibility

About

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

Full 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

Enrollment

130 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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