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Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
P.F.C. Sigma knee arthroplasty
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Silkeborg Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fixed bearing

Rotating platform

Arm Description

One of the 2 used implants.

One of the 2 used implants.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gait analysis
Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control.
DXA
Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant.

Full Information

First Posted
June 14, 2010
Last Updated
December 22, 2022
Sponsor
University of Aarhus
Collaborators
Regionshospitalet Silkeborg, Gigtforeningen, Protesekompagniet
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1. Study Identification

Unique Protocol Identification Number
NCT01150929
Brief Title
Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing
Official Title
Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
August 31, 2012 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Regionshospitalet Silkeborg, Gigtforeningen, Protesekompagniet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed bearing
Arm Type
Active Comparator
Arm Description
One of the 2 used implants.
Arm Title
Rotating platform
Arm Type
Active Comparator
Arm Description
One of the 2 used implants.
Intervention Type
Device
Intervention Name(s)
P.F.C. Sigma knee arthroplasty
Other Intervention Name(s)
PFC Sigma from DePuy International implants used.
Intervention Description
Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
Primary Outcome Measure Information:
Title
Radio Stereometric Analysis
Description
Patients are analysed with stereo x-rays to asses implant micromigration.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Gait analysis
Description
Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control.
Time Frame
12 months
Title
DXA
Description
Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Soballe, DMsc
Organizational Affiliation
Aarhus Sygehus THG
Official's Role
Study Chair
Facility Information:
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.orthoresearch.dk
Description
Orthopedic Research Aarhus, Denmark

Learn more about this trial

Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing

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