NCT02251535

Brief Summary

Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs. rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based motion capture evaluation. How do different levels of intra-operatively observed femoral rollback correlate to postoperative kinematics under weight bearing conditions? Does the modified design of the Attune Knee System influence the extent of the femoral rollback compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12 months follow up or is it reduced by, for example, remodelling of the posterior cruciate ligament?

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 23, 2014

Last Update Submit

September 25, 2014

Conditions

Gonarthrosis

Keywords

kinematic analysisfemoral rollbackmobile bearingcruciate retaining Primary Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • tibio-femoral anterior-posterior translation

    We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.

    at 12 months post operative

Secondary Outcomes (4)

  • quality of life

    at 12 months post operative

  • quality of life

    at 12 months post operative

  • quality of life

    at 12 months post operative

  • quality of life

    at 12 months post operative

Study Arms (3)

test group 1

EXPERIMENTAL

Retrospective test group 1 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining) with intraoperative high level rollback

Device: ATTUNE® Knee System

test group 2

EXPERIMENTAL

Retrospective test group 2 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining)with intraoperative low level rollback

Device: ATTUNE® Knee System

control group

EXPERIMENTAL

Control group (n=10, PFC® SIGMA® Knee System, rotatinq platform, cruciate retaininq)

Device: PFC® SIGMA® Knee System

Interventions

ATTUNE® Knee SystemDEVICE
test group 1test group 2
PFC® SIGMA® Knee SystemDEVICE
control group

Eligibility Criteria

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

You may qualify if:

  • Gender: Both, male and female
  • MinimumAge: 18 Years
  • Osteoarthritis Kellgren Grad lll or lV
  • Mechanical leg axis between 10'valgus and 10' varus
  • Tibial slope between 0' and 10'
  • BMI\< 40, participation consent

You may not qualify if:

  • Multidirectional instability of the knee
  • connective tissue diseases (Marfan syndrome, Ehlers-Danlos syndrome, scleroderma)
  • Nervous system diseases (Parkinson, multiple sclerosis, Peripheral neuropathy)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine Berlin Center for Musculoskeletal Surgery Department of Orthopaedics

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Georg N. Duda, Prof.

CONTACT

+49 30 450 559 079georg.duda@charite.de

Anne Zergiebel

CONTACT

+49 30 450 515 235anne.zergiebel@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 29, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

DE(1)