NCT00679120

Brief Summary

The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees.

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
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

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

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

December 1, 2022

Enrollment Period

8.4 years

First QC Date

May 14, 2008

Last Update Submit

November 21, 2023

Conditions

Osteoarthritis, Knee

Keywords

Unicompartmental osteoarthrosisRSABone-remodelling

Outcome Measures

Primary Outcomes (1)

  • Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed)

    2016

Secondary Outcomes (1)

  • Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.

    2016

Study Arms (3)

1

ACTIVE COMPARATOR

Cemented single pegged femur with standard tibial bearing tray

Device: Oxford Uni Knee

2

ACTIVE COMPARATOR

Cemented twin pegged femur with standard tibial bearing tray

Device: Oxford Uni Knee

3

ACTIVE COMPARATOR

Cementless tibial bearing tray and femur (porous coated and HA coated)

Device: Oxford Uni Knee

Interventions

Oxford Uni KneeDEVICE

Oxford Uni Knee inserted at the time of surgery

Also known as: Biomet, Oxford Uni Knee, single pegged femur, Biomet, Oxford Uni Knee,standard tibial bearing tray
1

Eligibility Criteria

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

You may qualify if:

  • Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis
  • Patients found suitable for UKA with telos stress-radiographs
  • Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis
  • Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint
  • Patients can only take part in one knee study
  • All age groups, in good condition and responsible adults
  • Informed, written compliance consent.

You may not qualify if:

  • Patients with neuromuscular or vascular diseases in the affected leg
  • Patients found to be unsuitable for UKA before or at surgery
  • Preoperative extensions defect greater than 10 degrees
  • Preoperative maximal flection of less than 100 degrees
  • Symptomatic patellofemoral osteoarthritis
  • Insufficiency with regard to ACL
  • Patients templated to a size XS or XL femoral component prior to surgery.
  • Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis
  • Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5
  • Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures)
  • Patients previous having PTO or other extensive knee surgery
  • Patients with metabolic bone disease
  • Patients with rheumatoid arthritis
  • Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment)
  • Patients who intermittently or continuously require treatment with systemic glucocorticoids
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

    PMID: 36422666DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Soballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

May 1, 2009

Primary Completion

October 1, 2017

Study Completion

August 1, 2024

Last Updated

November 22, 2023

Record last verified: 2022-12

Locations

DK(1)