MedDataX Logo

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

NCT ID: NCT01032538

Last Updated: 2023-12-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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!

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Unicondylar Knee Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with knee osteoarthritis

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* rheumatoid arthritis
* previous knee infection
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Martina Hansen's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tor Kjetil Nerhus

Consultant Orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tor Kjetil Nerhus, MD

Role: PRINCIPAL_INVESTIGATOR

Martina Hansens Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bærum Sykehus

Bærum, Akershus, Norway

Site Status

Akershus University Hospital

Lørenskog, Akershus, Norway

Site Status

Martina Hansens Hospital

Bærum, Bærum, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19441 (NSD)

Identifier Type: REGISTRY

Identifier Source: secondary_id

TKN-002

Identifier Type: -

Identifier Source: org_study_id