NCT01032538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

5.3 years

First QC Date

December 14, 2009

Results QC Date

October 25, 2013

Last Update Submit

November 10, 2023

Conditions

Keywords

Unicondylar Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score

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

    Preoperative until 2 years postoperatively

Secondary Outcomes (5)

  • Range of Motion

    Preoperative until 2 years postoperatively

  • Oxford Knee Score

    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

Study Arms (1)

Patients with knee osteoarthritis

Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital, Akershus University Hospital and Baerum hospital

You may qualify if:

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

You may not qualify if:

  • rheumatoid arthritis
  • previous knee infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bærum Sykehus

Bærum, Akershus, 1309, Norway

Location

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Martina Hansens Hospital

Bærum, Bærum, 1306, Norway

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Tor Kjetil Nerhus
Organization
Martina Hansens Hospital

Study Officials

  • Tor Kjetil Nerhus, MD

    Martina Hansens Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic surgeon

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 15, 2009

Study Start

November 1, 2003

Primary Completion

February 1, 2009

Study Completion

February 1, 2017

Last Updated

December 1, 2023

Results First Posted

January 13, 2015

Record last verified: 2023-11

Locations