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Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types
This study is not yet open for participant recruitment.
Verified by University of Aarhus, May 2008
Sponsors and Collaborators: University of Aarhus
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

MedlinePlus related topics: Knee Replacement Osteoarthritis
Drug Information available for: Cimetidine Cimetidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title: Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types.

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 as-sessed) [ Time Frame: 2014 ] [ 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: 2014 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: June 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Cemented single pegged femur with standard tibial bearing tray
Device: Oxford Uni Knee
Oxford Uni Knee inserted at the time of surgery
2: Active Comparator
Cemented twin pegged femur with standard tibial bearing tray
Device: Oxford Uni Knee
Oxford Uni Knee inserted at the time of surgery
3: Active Comparator
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)

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 se-ries of three different Oxford Uni Knees by studying:

  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 as-sessed).
  2. Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
  3. 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).
  4. 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.
  5. 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).
  6. If a fast bone-remodelling increases the risk of aseptic loosening (histomorphometric results co-mbined with RSA results and possible revision)
  7. Increased risk of aseptic loosening with cemented (two designs) compared to uncemented im-plants.
  8. If bone-remodelleing of the proximal tibia is dependend 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 suc-cess if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration.

The hypotheses are:

  1. RLL in relation to the tibial component is unimportant for fixation of the Oxford Uni Knee as assessed with DEXA and RSA.
  2. There is very little wear of the polyethylene in the course of a 5 year follow-up as assessed with RSA.
  3. The femoral component is expected to remain fixed throughout the entire period of follow-up.
  4. Function assessment as ROM (range of motion) after UKA is satisfactory and generally better than after TKA.
  5. 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.
  6. No difference in clinical outcome between the three prosthetic types.
  7. The rone-remodellering 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-remodelling, 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:

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

Exclusion Criteria:

  1. Patients with neuromuscular or vascular diseases in the affected leg
  2. Patients found to be unsuitable for UKA before or at surgery
  3. Preoperative extensions defect greater than 10 degrees
  4. Preoperative maximal flection of less than 100 degrees
  5. Symptomatic patellofemoral osteoarthritis
  6. Insufficiency with regard to ACL
  7. Patients templated to a size XS or XL femoral component prior to surgery.
  8. Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis
  9. Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5
  10. Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures)
  11. Patients previous having PTO or other extensive knee surgery
  12. Patients with metabolic bone disease
  13. Patients with rheumatoid arthritis
  14. Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment)
  15. Patients who intermittently or continuously require treatment with systemic glucocorticoids
  16. Non-Danish citizens
  17. Insufficient command of the Danish language (read and speak)
  18. Senile dementia
  19. Misuse of drugs or Alcohol
  20. Serious psychiatric illness
  21. Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy
  22. Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
  23. Systemic hip or back condition
  24. Employed by the department of orthopaedic surgery
  25. On-going case involving work injury of the knee
  26. 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
Aarhus, Denmark, 8000
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

Responsible Party: Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C ( Professor Kjeld Soballe )
Study ID Numbers: 20070258
Study First Received: May 14, 2008
Last Updated: May 15, 2008
ClinicalTrials.gov Identifier: NCT00679120  
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Unicompartmental osteoarthrosis
RSA
Bone-remodelling

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
 Arthritis
Rheumatic Diseases
Cimetidine

ClinicalTrials.gov processed this record on January 15, 2009



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