NCT04172129

Brief Summary

The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

5.7 years

First QC Date

November 19, 2019

Last Update Submit

November 25, 2019

Conditions

Primary and Secondary CoxarthrosisDysplasia CoxarthrosisPost-traumatic Necrosis of the Femoral Head

Keywords

NanosTHAMBRSA

Outcome Measures

Primary Outcomes (2)

  • Evaluation of migration pattern of the Nanos stem

    Measuring migration used the model-based RSA method

    2 years

  • Change in quality of life

    Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score * Minimum Value: 0 (worst outcome) * Maximum Value: 100 (best outcome)

    2 years

Secondary Outcomes (7)

  • Harris Hip Score

    2 years

  • University of California, Los Angeles (UCLA) scale

    2 years

  • Pain Visual Analogue Scale

    2 years

  • Postel Merle d'Aubigné-Score

    2 years

  • Hip Disability and Ostheoarthritis Outcome Score

    2 years

  • +2 more secondary outcomes

Study Arms (1)

NANOS

NANOS™ Neck Preserving Hip Stem

Device: Total Hip Arthroplasty

Interventions

Total Hip ArthroplastyDEVICE
NANOS

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients identified in the primary care clinic with need for total hip arthroplasty

You may qualify if:

  • Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
  • Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
  • Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
  • Subject was 30 to 65 (inclusive) years of age at time of surgery.

You may not qualify if:

  • Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
  • Subject had a local or systemic infection.
  • Subject had previously diagnosed osteoporosis.
  • Subject had a femoral neck angle of \>145°.
  • Subject had a femoral neck angle of \<125°.
  • Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
  • Subject had a documented allergy against elements of the implanted device.
  • Subject had a neurological disease with changed motor function.
  • Subject was pregnant.
  • Subject had a Body Mass Index (BMI) \> 30.
  • Subject suffered from alcoholism or addictive disorders.
  • Subject needed a revision hip arthroplasty.
  • Subject had an insufficient command of the language to understand patient information and consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopädische Klinik der Medizinischen Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Henning Windhagen, Prof. Dr. med.

    Orthopädische Klinik der Medizinischen Hochschule Hannover

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

April 26, 2011

Primary Completion

January 4, 2017

Study Completion

February 15, 2017

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

DE(1)