NCT01693627

Brief Summary

A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:

  • To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)
  • To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)
  • To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

5 years

First QC Date

March 21, 2012

Last Update Submit

February 23, 2016

Conditions

Arthritis of the Hip

Outcome Measures

Primary Outcomes (4)

  • Polyethylene wear

    Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis

    After 5 years of follow-up

  • Component migration-cup

    Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.

    After 5 years of follow-up

  • Periprosthetic bone mineral density

    Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.

    After 2 years of follow-up

  • Component migration-stem

    Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.

    After 5 years of follow-up

Secondary Outcomes (1)

  • Clinical outcome

    After 5 years of follow-up

Study Arms (4)

Pinnacle/Corail with collar

ACTIVE COMPARATOR

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Device: Pinnacle/Corail with collar

Marathon/Corail with collar

ACTIVE COMPARATOR

Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Device: Marathon/Corail with collar

Pinnacle/Corail without collar

ACTIVE COMPARATOR

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Device: Pinnacle/Corail without collar

Marathon/Corail without collar

ACTIVE COMPARATOR

Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Device: Marathon/Corail without collar

Interventions

Pinnacle/Corail with collarDEVICE

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Pinnacle/Corail with collar
Marathon/Corail with collarDEVICE

Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Marathon/Corail with collar
Pinnacle/Corail without collarDEVICE

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Pinnacle/Corail without collar
Marathon/Corail without collarDEVICE

Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Marathon/Corail without collar

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.

You may not qualify if:

  • Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
  • BMI \> 35,
  • insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
  • liver disease,
  • Paget's disease,
  • dementia or lack of compliance for other reasons,
  • uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, Haukeland University Hospital

Bergen, 5096, Norway

Location

Study Officials

  • Leif I Havelin, MD, PhD

    Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

    STUDY DIRECTOR

  • Benedikt A Jonsson, MD

    Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

  • Geir Hallan, MD, PhD

    Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

  • Ove Furnes, MD, PhD

    Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

    STUDY CHAIR

  • Clara G Gjesdal, MD, PhD

    Department of Rheumatology, Haukeland University Hospital, Bergen, Norway

    STUDY CHAIR

  • Kristin Haugan, MA

    Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway

    STUDY CHAIR

  • Arne K Skredderstuen, MD

    Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

    STUDY CHAIR

  • Terje Stokke

    Department of Radiology, Haukeland University Hospital, Bergen, Norway

    STUDY CHAIR

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

March 21, 2012

First Posted

September 26, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2022

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

NO(1)