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Completed

NCT Number: NCT01032538

Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bærum Sykehus, Bærum, Akershus, Norway

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About this study

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with medial knee osteoarthritis
  • admitted for unicondylar knee replacement
  • age 50-80 years

Exclusion criteria

  • rheumatoid arthritis
  • previous knee infection

Treatment and study plan

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: Preoperative until 2 years postoperatively

    Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.

Secondary outcomes

  1. Range of Motion

    Time frame: Preoperative until 2 years postoperatively

  2. Oxford Knee Score

    Time frame: Preoperative until 2 years postoperatively

  3. UCLA Score

    Time frame: Preoperative until 2 years postoperatively

  4. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 10 years postoperatively

  5. Oxford Knee Score

    Time frame: 10 years postoperatively

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement - A Prospective Longitudinal Study With Repetitive Measures of KOOS in 100 Patients

Important dates

Study start
2003
Primary completion
2009
Study completion
2017
First posted
Dec 15, 2009
Registry last updated
Dec 1, 2023

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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