Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types - Full Text View

Sponsor:	University of Aarhus
Collaborators:	Aarhus University Hospital Vejle Hospital Biomet, Inc.
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00679120

Purpose

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.

Condition	Intervention
Osteoarthritis, Knee	Device: Oxford Uni Knee

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

Drug Information available for: Cimetidine Cimetidine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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) [ Time Frame: 2016 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays. [ Time Frame: 2016 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	May 2009
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	October 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Cemented single pegged femur with standard tibial bearing tray	Device: Oxford Uni Knee Oxford Uni Knee inserted at the time of surgery Other Names: Biomet, Oxford Uni Knee, single pegged femur Biomet, Oxford Uni Knee,standard tibial bearing tray
Active Comparator: 2 Cemented twin pegged femur with standard tibial bearing tray	Device: Oxford Uni Knee Oxford Uni Knee inserted at the time of surgery Other Names: Biomet, Oxford Uni Knee, twin pegged femur Biomet, Oxford Uni Knee, standard tibial bearing tray
Active Comparator: 3 Cementless tibial bearing tray and femur (porous coated and HA coated)	Device: Oxford Uni Knee Oxford Uni Knee inserted at the time of surgery (porous coated and HA coated) Other Names: Biomet, Oxford Uni Knee, cementless femur Biomet, Oxford Uni Knee, cementless tibial bearing tray

Detailed Description:

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 series of three different Oxford Uni Knees by studying:

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).
Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
Changes in periprosthetic bone mineral density between the three randomized groups evaluated in the proximal tibia and distal femur on the surgical side and on the unaffected tibial condyle area (BMD).
Clinical function of the Uni Knee evaluated by a score system using a recent Danish adaptation of the Oxford Knee Score that consists of a questionnaire filled-out by the patient with 12 simple questions on pre-and postoperative assessment of the ADL.
Analysis of wear of the mobile polyethylene (meniscus) including a methodical study as to whether the technique requires weightbearing (standing) stereoroentgenograms or whether non-weightbearing stereoroentgenograms can be used (assessed with Model Based RSA).
If a fast bone-remodeling increases the risk of aseptic loosening (histomorphometric results combined with RSA results and possible revision)
Increased risk of aseptic loosening with cemented (two designs) compared to uncemented im-plants.
If bone-remodeling of the proximal tibia is dependent on gender and age.

The study would be considered a success if all designs of the prostheses are firmly fixed and remain so during the entire period of study, that is, no increasing migration is seen using RSA. It would be a success if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration.

The hypotheses are:

RLL in relation to the tibial component is unimportant for fixation of the Oxford Uni Knee as assessed with DEXA and RSA.
There is very little wear of the polyethylene in the course of a 5 year follow-up as assessed with RSA.
The femoral component is expected to remain fixed throughout the entire period of follow-up.
Function assessment as ROM (range of motion) after UKA is satisfactory and generally better than after TKA.
All three prosthetic designs are expected to migrate minimally and remain fixed throughout the follow-up period, but the uncemented design is expected to be superior to the cemented design.
No difference in clinical outcome between the three prosthetic types.
The bone-remodeling rate in the medial periarticular tibia bone increases the risk of aseptic loosening.

The primary parameters of effect are RLL, RSA and DEXA. The secondary parameters of effect are bone-remodeling, wear analysis, Oxford Knee Score (ADL) and ROM.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Non-Danish citizens
Insufficient command of the Danish language (read and speak)
Senile dementia
Misuse of drugs or Alcohol
Serious psychiatric illness
Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy
Serious systemic disease (e.g.. hemiparesis and severe Parkinsonism)
Systemic hip or back condition
Employed by the department of orthopaedic surgery
On-going case involving work injury of the knee
Patients with poor dental status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679120

Contacts

Contact: Maiken Stilling, MD

0045 89497466

mm-p@dadlnet.dk

Locations

Denmark
Orthopaedic Center, Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8000
Contact: Maiken Stilling, MD 0045 89497466 mm-p@dadlnet.dk
Contact: Kjeld Soballe, MD, Prof. 0045 89497425 kjelsoeb@rm.dk
Sub-Investigator: Maiken Stilling, MD, PhD
Sub-Investigator: Frank Madsen, MD
Sub-Investigator: Anders Odgaard, MD, DMSc
Sub-Investigator: Per Wagner Kristensen, MD
Sub-Investigator: Lone Romer, MD
Principal Investigator: Kjeld Soballe, MD, DMSc

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Vejle Hospital

Biomet, Inc.

Investigators

Principal Investigator:

Kjeld Soballe, MD, Prof.

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

More Information

No publications provided

Responsible Party:	Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C
ClinicalTrials.gov Identifier:	NCT00679120 History of Changes
Other Study ID Numbers:	20070258
Study First Received:	May 14, 2008
Last Updated:	June 16, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Unicompartmental osteoarthrosis
RSA
Bone-remodelling

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012