NCT02404727

Brief Summary

The aim of this project is to investigate prosthesis fixation in the bone, respectively cemented and uncemented operation method of Avantage® dual-mobility acetabular cup in elderly patients, wear of the plastic in dual-mobility hip prosthesis and evaluate the clinical function, patient satisfaction and possible complications. Patients included in this study suffer from osteoarthritis of the hip.

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 not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 24, 2018

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

January 21, 2015

Last Update Submit

October 22, 2018

Conditions

Osteoarthritis, HipArthropathy of Hip

Keywords

Osteoarthritis, Hipacetabular fixationdual mobility cupRadiostereometric AnalysisDual-Energy Radiographic AbsorptiometryAccelerometrytotal hip arthroplastyintra-prosthetic dislocation

Outcome Measures

Primary Outcomes (1)

  • Cup migration, measured by Radiostereometric Analysis

    cup migration in the cemented and cementless cups are measures with Radiostereometric Analysis. The primary endpoint was proximal cup migration (y-axis) at the 2-year follow-up.

    5 years

Secondary Outcomes (4)

  • Polyethylene wear, measured by Radiostereometric Analysis

    5 years

  • Bone mineral density, measured by dual energy X-ray Absorption (DXA) scans

    5 years

  • PROMS

    5 years

  • Physical activity monitoring and classification, motion analysis.

    5 years

Study Arms (2)

cup fixation cemented

ACTIVE COMPARATOR

30 of the 60 patients will be randomized to cemented cup fixation

Procedure: cup fixationDevice: Avantage® Cup

cup fixation cementless

ACTIVE COMPARATOR

30 of the 60 patients will be randomized to cementless cup fixation

Procedure: cup fixationDevice: Avantage® Cup

Interventions

cup fixationPROCEDURE

All patients will preoperatively, 3 months, 1 year, 2 year and 5 year have the hip DXA scanned, answer PROM, X-ray for RSA analysis and wear measurements, and wear accelerometry chip 14 days prior each outward clinic visit for movement analysis.

cup fixation cementedcup fixation cementless
Avantage® CupDEVICE
cup fixation cementedcup fixation cementless

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Both men and women with osteoarthritis of the hip joint.
  • Patients with adequate bone quality for insertion of a cementless acetabular component.
  • Age 70 years and above, capable and empowered.
  • Informed written consent.
  • The patient may only participate with one hip.

You may not qualify if:

  • Patients with severe nerve, muscle and vascular disease in the lower extremities
  • Patients that during surgery are assessed not suitable for treatment with cementless hip prosthesis.
  • Patients with severe osteoporosis (T-score \< 4.0) as assessed by DXA scan before surgery..
  • Patients with previous hip fractures.
  • Patients who have previously undergone correction of bone malalignment of the hip or other major hip surgery.
  • Patients in need of a different stem that the Exeter stem (Stryker inc.).
  • Patients with metabolic disease of the bone or arthritis.
  • Patients who needing treatment with corticosteroids in tablet form (\> 3 months / year).
  • Patients with metastatic cancer and / or radiation therapy and / or chemotherapy.
  • Patients without Danish citizenship / patients who do not speak and understand Danish.
  • Senile dementia.
  • Alcoholism (more than 21 drinks / week for men and more than 14 drinks / week for women).
  • Severe psychiatric illness.
  • Severe systemic disease affecting gait and mobilization (e.g. Parkinson's disease or hemiplegia). Very poor dental status (risk of infection).
  • Senile dementia / lost impartiality
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Hand, Hip and Knee Surgery, Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Torben B. Hansen, Ph.D., Professor

    Department of Orthopaedic Surgery, Hospital Unit West, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

March 31, 2015

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2018

Last Updated

October 24, 2018

Record last verified: 2014-12

Locations

DK(1)