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

An observational study of Osteoarthritis, run by Vestre Viken Hospital Trust at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Osteoarthritis
How many people: 99 participants
Where: 3 sitesNorway
Study dates: Nov 2003to Feb 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

rheumatoid arthritis
previous knee infection

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

Bærum Sykehus
Bærum, Akershus, 1309
Martina Hansens Hospital
Bærum, Bærum, 1306
Akershus University Hospital
Lørenskog, Akershus, 1478

Other trials in Norway

About this study

Official 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

Read the detailed description

Conditions: Osteoarthritis
Keywords: Unicondylar Knee Replacement
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01032538
Study group	Role	What they receive
Patients with knee osteoarthritis		Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Range of Motion
Measured: Preoperative until 2 years postoperatively
Oxford Knee Score
Measured: Preoperative until 2 years postoperatively
UCLA Score
Measured: Preoperative until 2 years postoperatively
Knee Injury and Osteoarthritis Outcome Score
Measured: 10 years postoperatively
Oxford Knee Score
Measured: 10 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Feb 2017

First posted15 Dec 2009 (estimated)
Study startNov 2003
Primary completionFeb 2009
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01032538
Sponsor's protocol ID: TKN-002
Other IDs: 19441 (NSD)
Status last verified: Nov 2023
First submitted: 14 Dec 2009
Last updated: 1 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01032538
Acronym / sponsor ID: TKN-002
Conditions: Osteoarthritis
Keywords: Unicondylar Knee Replacement
Study type: Observational
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Vestre Viken Hospital TrustUniversity, hospital or other
Collaborators: South-Eastern Norway Regional Health Authority
Study start: Nov 2003
Primary completion: Feb 2009 (actual)
Study completion: Feb 2017 (actual)
First posted: 15 Dec 2009 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with knee osteoarthritis	–	–Patients with knee osteoarthritis that are about to get an operation with oxford unicondylar knee

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital, Akershus University Hospital and Baerum hospital

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

rheumatoid arthritis
previous knee infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

5 secondary outcomes

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

Results and safety

Results posted to the registry on 13 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Knee Osteoarthritis	99	99

Primary outcome: Knee Injury and Osteoarthritis Outcome Score

Time frame: Preoperative until 2 years postoperatively. Mean (95% Confidence Interval). Unit: units on a scale

Measure	KOOS Pain 2 Years n = 96	KOOS ADL 2 Years n = 96
Value	85.5 (82 to 89)	88.2 (85 to 91)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Knee Osteoarthritis	5 of 96 (5.2%)	0 of 96 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tor Kjetil Nerhus, MD principal investigator

Martina Hansens Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by Vestre Viken Hospital Trust at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score (time frame: Preoperative until 2 years postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01032538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.