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

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT01032538
• Lead Sponsor: Martina Hansen's Hospital

Brief Summary

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.

Detailed Description

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!

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2009-02
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Results First Submitted: 2013-10-25
• Results First Submitted QC: 2015-01-03
• Results First Posted: 2015-01-13
• Study Completion: 2017-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

Exclusion criteria

• rheumatoid arthritis
• previous knee infection

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	Preoperative until 2 years postoperatively	Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	Preoperative until 2 years postoperatively
UCLA Score	Preoperative until 2 years postoperatively
Knee Injury and Osteoarthritis Outcome Score	10 years postoperatively
Oxford Knee Score	10 years postoperatively

Trial Locations

Locations (3)

Bærum Sykehus; 🇳🇴 Bærum, Akershus, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway

Martina Hansens Hospital; 🇳🇴 Bærum, Norway