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OpenTrials
Completed

NCT Number: NCT03434600

Comparison of Oxford UKA and Sigma UKA With RSA.

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Replacement Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee RSA Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxford UKA vs Sigma UKA

Other

Primary outcomes

  1. Migration of prosthesis

    Time frame: 2 years follow-up

    RSA

Secondary outcomes

  1. Bone mineral density

    Time frame: 2 years follow-up

    DXA

  2. Polyethylene wear

    Time frame: 5 years follow-up

    Weight-bearing RSA

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2017
First posted
Feb 15, 2018
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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