Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)

• Sponsor: Vestre Viken Hospital Trust (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02791477
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 80
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty	Device: Attune FB PS knee arthroplasty	N/A

Detailed Description

Total knee arthroplasty is a well documented and efficient treatment method for degenerative knee arthritis. Nevertheless it is reported that 15-20% of patients are not satisfied with the result. Some of the complaints are anterior knee pain, mid flexion instability and range of motion. Attune Fixed Bearing Posterior Stabilized knee have been developed to address the common complaints after knee arthroplasty surgery . The investigators like to use the Attune Fixed Bearing Posterior Stabilized knee with patella resurfacing on 65 of Our departments eligible patients to evaluate the functional results. Our primary outcome measure is change in Knee Osteoarthritis Outcome Score.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 1, 2020
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Attune FB PS Attune FB PS knee arthroplasty	Device: Attune FB PS knee arthroplasty

Outcome Measures

Primary Outcome Measures

1. Knee injury and Osteoarthritis Outcome Score - (KOOS) [2 years postoperative]

   Knee injury and Osteoarthritis Outcome Score

Secondary Outcome Measures

1. Forgotten Joint Score (FJS-12) [2 years postoperative]

   Forgotten Joint Score -12. Translated Norwegian version

2. Quality of Life (EQ-5D) [2 years postoperative]

   Quality of life questionnaire

3. University of California Los Angeles-Activity score [2 years postoperative]

   Record change in Activity level

4. Range of Movement (ROM) [2 years postoperative]

   Range of movement pre- and postoperative

5. Stair climbing test functional test [2 years postoperative]

   Time spend on walking up and down 9 stairs

6. 30 seconds stand up functional test [2 years postoperative]

   Number of stand ups from a chair in 30 seconds

7. 40 meters walking functional test [2 years postoperative]

   Time spend on walking 40 meters

8. Visual Analogue Scale Satisfaction (VAS-satisfaction) [2 years postoperative]

   Scale for assesment of the satisfaction with the arthroplasty

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vestre Viken HT, Baerum Hospital, Department of Medical Research	Sandvika	Akershus	Norway	3004

Sponsors and Collaborators

• Vestre Viken Hospital Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vestre Viken Hospital Trust
• ClinicalTrials.gov Identifier: NCT02791477
• Other Study ID Numbers: Attune 2016
• First Posted: Jun 6, 2016
• Last Update Posted: Apr 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Vestre Viken Hospital Trust: Attune

Study Results

No Results Posted as of Apr 14, 2021