NCT03059927

Brief Summary

The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

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
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 20, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

February 16, 2017

Last Update Submit

April 19, 2017

Conditions

Gonarthrosis; PrimaryDegenerative Joint Disease of Knee

Keywords

Cruciate retainingAnterior stabilizedPosterior stabilizedPosterior cruciate ligamentDegenerative knee joint diseaseKnee injury and Osteoarthritis Outcome ScoreKinematic radiostereometry

Outcome Measures

Primary Outcomes (1)

  • Knee injury and osteoarthritis outcome score (KOOS)

    KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.

    Pre-operative, 1, 2 and 5 years

Secondary Outcomes (6)

  • Oxford knee score (OKS)

    Pre-operative, 1, 2 and 5 years

  • EQ-5D-5L

    Pre-operative, 1, 2 and 5 years

  • Range of motion (ROM)

    Pre-operative, 6 weeks, 3, 12, 24 and 60 months

  • Kinematic radiostereometric analysis (RSA)

    After 12 months

  • Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs

    Pre-operative, 3, 12, 24 and 60 months

  • +1 more secondary outcomes

Study Arms (3)

Knee arthroplasty, Cruciate retaining

ACTIVE COMPARATOR

Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.

Procedure: Knee arthroplasty, Cruciate retaining

Knee arthroplasty, Anterior stabilized

ACTIVE COMPARATOR

Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.

Procedure: Knee arthroplasty, Anterior stabilized

Knee arthroplasty, Posterior stabilized

ACTIVE COMPARATOR

Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.

Procedure: Knee arthroplasty, Posterior stabilized

Interventions

Knee arthroplasty, Cruciate retainingPROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design

Knee arthroplasty, Cruciate retaining
Knee arthroplasty, Anterior stabilizedPROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design

Knee arthroplasty, Anterior stabilized
Knee arthroplasty, Posterior stabilizedPROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design

Knee arthroplasty, Posterior stabilized

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis
  • Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
  • Intact PCL (assessed preoperatively and verified during surgery)
  • Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
  • Body mass index ≤ 35 kg/m2
  • ASA (American Society of Anaesthesiologists) score I or II
  • Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

You may not qualify if:

  • Prior ACL (anterior cruciate ligament) surgery
  • Impaired collateral ligaments
  • Secondary osteoarthritis of the knee
  • Previous osteotomy
  • Rheumatic disease
  • Flexion less than 90 degrees
  • Flexion contracture over 10 degrees
  • Peripheral neuropathy
  • Malignancy
  • Patients who do not speak Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haugesund Rheumatism Hospital

Haugesund, 5528, Norway

NOT YET RECRUITING

Lovisenberg Diaconal Hospital

Oslo, 0446, Norway

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Arild Aamodt, MD, PhD

    Lovisenberg Diaconal Hospital, Oslo, Norway

    STUDY DIRECTOR

Central Study Contacts

Yasser Rehman, MD

CONTACT

+4798477583yare@lds.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)