NCT01150929

Brief Summary

The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs. The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

5.5 years

First QC Date

June 14, 2010

Last Update Submit

December 22, 2022

Conditions

Osteoarthritis

Keywords

Knee arthroplastyRSADXAGait analysisMotion analysis

Outcome Measures

Primary Outcomes (1)

  • Radio Stereometric Analysis

    Patients are analysed with stereo x-rays to asses implant micromigration.

    24 months

Secondary Outcomes (2)

  • Gait analysis

    12 months

  • DXA

    24 months

Study Arms (2)

Fixed bearing

ACTIVE COMPARATOR

One of the 2 used implants.

Device: P.F.C. Sigma knee arthroplasty

Rotating platform

ACTIVE COMPARATOR

One of the 2 used implants.

Device: P.F.C. Sigma knee arthroplasty

Interventions

P.F.C. Sigma knee arthroplastyDEVICE

Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene

Also known as: PFC Sigma from DePuy International implants used.
Fixed bearingRotating platform

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.

You may not qualify if:

  • Neurologic disease with impact on gait.
  • Orthopaedic disease ipsilateral hip joint.
  • Patients outside the age limits.
  • No informed consent signed.
  • Patients suffering from dementia.
  • Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
  • Patients who later develop deep venous thrombosis or infection in the operated knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Soballe, DMsc

    Aarhus Sygehus THG

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 25, 2010

Study Start

March 1, 2007

Primary Completion

August 31, 2012

Study Completion

December 31, 2014

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations

DK(1)