NCT02791477

Brief Summary

Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6 weeks, 3, 6, 12 and 24 months postoperative.

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
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

4.2 years

First QC Date

May 11, 2016

Last Update Submit

April 13, 2021

Conditions

Knee Arthroplasty

Keywords

Attune

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score - (KOOS)

    Knee injury and Osteoarthritis Outcome Score

    2 years postoperative

Secondary Outcomes (8)

  • Forgotten Joint Score (FJS-12)

    2 years postoperative

  • Quality of Life (EQ-5D)

    2 years postoperative

  • University of California Los Angeles-Activity score

    2 years postoperative

  • Range of Movement (ROM)

    2 years postoperative

  • Stair climbing test functional test

    2 years postoperative

  • +3 more secondary outcomes

Study Arms (1)

Attune FB PS

OTHER

Attune FB PS knee arthroplasty

Device: Attune FB PS knee arthroplasty

Interventions

Attune FB PS knee arthroplastyDEVICE
Attune FB PS

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 50-80 years eligible for total knee arthroplasty at our hospital

You may not qualify if:

  • Patients unable to cooperate
  • Larger deformity that not suitable for a Posterior Stabilized total knee prostheses.
  • Revision operation
  • Diagnosed with inflammatory arthritis
  • Previously septic arthritis in the current knee joint
  • Local malignancy/general bone metastases
  • Serious Medical conditions that inflict on the walking ability
  • Active infections, latent infections og increased risk og infection
  • Previously arthrodeses or not well functioned arthroplasties in hips, knees or ankles.
  • Neurologic illness with symptoms from the current limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken HT, Baerum Hospital, Department of Medical Research

Sandvika, Akershus, 3004, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

June 6, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2020

Study Completion

December 31, 2022

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

NO(1)