Patellofemoral Pain After Unicondylar Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Medical University Innsbruck.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01407042
First received: July 26, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.

We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.

In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.


Condition Intervention
Mobile-bearing Unicondylar Knee Arthroplasty
Procedure: mobile-bearing unicondylar knee arthroplasty

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Size of anterior femoral notch [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    Required cartilage / bone removal adjacent to the femoral implant

  • Kujala Score changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • KOOS questionnaire changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Radionuclide tracer uptake at the surgically created notch [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2011
Groups/Cohorts Assigned Interventions
mb-UKA
Patients with unicondylar osteoarthritis of the knee
Procedure: mobile-bearing unicondylar knee arthroplasty
mobile-bearing unicondylar knee arthroplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university

Criteria

Inclusion Criteria:

- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment

Exclusion Criteria:

  • failed upper tibial osteotomy
  • insufficiency of the collateral or anterior cruciate ligaments
  • a fixed varus or valgus deformity (not passively correctable) above 15°
  • a flexion deformity greater than 15°
  • rheumatoid arthritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407042

Contacts
Contact: Michael C Liebensteiner, MD, PhD +43 512 504 80547 michael.liebensteiner@i-med.ac.at

Locations
Austria
Innsbruck Medical University Recruiting
Innsbruck, Austria, 6020
Contact: Martin Krismer, Prof.    +43 512 504 22691      
Principal Investigator: Michael C Liebensteiner, MD, PhD         
Sponsors and Collaborators
Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Dept. Orthopaedic Surgery, Innsbruck Medical University
ClinicalTrials.gov Identifier: NCT01407042     History of Changes
Other Study ID Numbers: PFJ-UKA-1
Study First Received: July 26, 2011
Last Updated: June 25, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University Innsbruck:
unicondylar knee arthroplasty
mobile-bearing
patellofemoral pain

ClinicalTrials.gov processed this record on August 20, 2014