NANOS Neck Preserving Hip Stem

Primary Osteoarthritis Clinical Trial

— NANOS  

Official title:

A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04036279
• Other study ID #: R11014-1
• Status: Terminated
• Start date: January 21, 2010
• Est. completion date: March 2023

Study information

• Verified date: June 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Total Hip Arthroplasty

Locations

Country	Name	City	State
Germany	University Marburg, Orthopedics and Rheumatology	Marburg
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Poland	Samodzielny Publiczny Wojewodzki Spital	Piekary Slaskie

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra- and peri-operative device-related adverse events (AE) and complications up to discharge	Any reported safety events or complications up to 10 years post study procedure	10 years
Other	Postoperative AE up to 10 years	Any reported safety events or complications up to 10 years post study procedure	10 years
Other	Evaluation of function, range of motion and pain assessed by Harris Hip Score	Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).; HHS scores for each subject will further be categorized as follows: Excellent (90-100); Good (80-89); Fair (70-79); Poor (60-69) and; Very poor (<60).	10 years
Other	Evaluation of function, range of motion and pain as assessed by HOOS score	HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	10 years
Other	Evaluation of function, range of motion and pain as assessed by UCLA Activity Rating	UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function.	10 years
Other	Radiographic changes as defined by resorption, radiolucent lines, osteolysis, hypo- and hypertrophy, implant migration or loosening	Any radiographic changes up to 10 years post study procedure	10 years
Primary	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