Comparison of Oxford UKA and Sigma UKA With RSA.
Primary Purpose
Knee Osteoarthritis, Knee Replacement, RSA
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxford UKA vs Sigma UKA
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- All eligable patients with medial osteoarthritis of the knee.
Exclusion Criteria:
- - Inflammatory arthritis.
- Patients who are not able to participate in the fast-track surgery program.
- Patients with a contralateral knee arthroplasty.
- Patients who are unable to provide informed consent.
- Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
- Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
- On-going case involving work injury of the knee.
- Female patients with a wish of becoming pregnant in the study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oxford
Sigma
Arm Description
Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
Patients receiving a Sigma UKA, which is the experimental treatment.
Outcomes
Primary Outcome Measures
Migration of prosthesis
RSA
Secondary Outcome Measures
Bone mineral density
DXA
Polyethylene wear
Weight-bearing RSA
Full Information
NCT ID
NCT03434600
First Posted
February 9, 2018
Last Updated
May 16, 2019
Sponsor
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT03434600
Brief Title
Comparison of Oxford UKA and Sigma UKA With RSA.
Official Title
Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.
Hypothesis:
H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.
H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.
H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.
H4: BMD of the proximal tibia does not influence migration of the tibial component
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Replacement, RSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxford
Arm Type
Active Comparator
Arm Description
Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
Arm Title
Sigma
Arm Type
Experimental
Arm Description
Patients receiving a Sigma UKA, which is the experimental treatment.
Intervention Type
Other
Intervention Name(s)
Oxford UKA vs Sigma UKA
Primary Outcome Measure Information:
Title
Migration of prosthesis
Description
RSA
Time Frame
2 years follow-up
Secondary Outcome Measure Information:
Title
Bone mineral density
Description
DXA
Time Frame
2 years follow-up
Title
Polyethylene wear
Description
Weight-bearing RSA
Time Frame
5 years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All eligable patients with medial osteoarthritis of the knee.
Exclusion Criteria:
- Inflammatory arthritis.
Patients who are not able to participate in the fast-track surgery program.
Patients with a contralateral knee arthroplasty.
Patients who are unable to provide informed consent.
Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
On-going case involving work injury of the knee.
Female patients with a wish of becoming pregnant in the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daan Koppens
Organizational Affiliation
Hospital Unit Vest
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Oxford UKA and Sigma UKA With RSA.
We'll reach out to this number within 24 hrs