NCT00138853

Brief Summary

The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation into the tibia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 19, 2022

Status Verified

February 1, 2020

Enrollment Period

6.4 years

First QC Date

August 29, 2005

Last Update Submit

December 14, 2022

Conditions

Osteoarthritis

Keywords

RSAGenoarthrosisKnee arthroplastyMicromotion of polyethylene liner

Outcome Measures

Primary Outcomes (1)

  • Polyethylene wear (mm) of the medial and lateral knee prosthesis compartments at 5 years followup measured with model-based radiostereometry

    Up to 5 years

Secondary Outcomes (3)

  • Difference in MPTM (mm) tibial component migration from 2-5 years (stabilization 3) measured with model-based radiostereometry

    up to 5 years

  • Number of implants migrating above 0.2mm MTPM from 1-2 years (stabilization 2) and 2-5 years (stabilization 3) measured with model-based radiostereometry

    Up to 5 years

  • Osteolysis (radiolucent lines >1 mm) in the tibial periprosthetic region measured on radiographs

    Up to 5 years

Study Arms (2)

Tantalum knee

ACTIVE COMPARATOR

Tantalum Tibial component, uncemented

Device: Tibial component

Titanium Knee

ACTIVE COMPARATOR

Titanium Tibial Component, screw fixed

Device: Tibial component

Interventions

Tibial componentDEVICE

Tibial component inserted at the time of surgery

Also known as: NexGen Tantalum Tibial Plate, NexGen Titanium Tibial Plate, screw fixed
Tantalum kneeTitanium Knee

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with one- or double-sided primary knee arthrosis.
  • Patients with a sufficient bone quality for implantation of an uncemented prosthesis.
  • Informed and written patient consent.

You may not qualify if:

  • Patients with neuromuscular or vascular diseases in the affected leg.
  • Patients who peroperatively are estimated unsuitable for an uncemented knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
  • Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
  • Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporosis.
  • Patients with fracture sequelae.
  • Women, who are pregnant or are at risk of getting pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital.

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark

    PRINCIPAL INVESTIGATOR

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

August 29, 2005

First Posted

August 30, 2005

Study Start

November 1, 2003

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 19, 2022

Record last verified: 2020-02

Locations

DK(1)