Knee OsteoarthritisUKA or TKA?NCT02563756
Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
A study testing Unicompartmental knee replacement and Total knee replacement in people with Knee Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement. Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Unicompartmental knee replacement and Total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medial gonarthritis, (Kellgren 3b-4)
- correctible varus deformity less than 10 degrees
- intact ACL
- proficient in written and spoken swedish
Who cannot join
- Valgus gonarthritis
- flexion deformity of 10 degrees
- knee flexion of less than 100 degrees
- previous high tibial osteotomy
- neuromuscular disorders of lower extremities
- symptomatic osteoarthritis of the contralateral knee or any hip.
Trial locations and contacts
1 site in 1 country.
Nicolas Martinez, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Carl Aulin, MD, carl.aulin@karolinska.se
Nicolas Martinez, MD, +46709900089, nicolas.martinez-carranza@karolinska.se
About this study
Official title: Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement.
Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome.
Read the detailed description
Objective: The investigators aim with the present study was to compare patient related outcome measurements, knee function and muscle mass in patients operated with an UKR or a TKR for medial gonarthritis.
Hypothesis: The investigators hypothesize that a greater number of patients might benefit from a less invasive surgery in terms of increased quality of life, function and muscle mass.
Primary Outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT.
Secondary outcomes: Functional tests (timed up and go, 30s sit and stand, forward reach, forward step down, 6 min walk and 40 m walk test), knee strength (Biodex isokinetic dynamometer) and patient reported pain on a visual analogue scale (VAS). A number of PROMs: Health related quality of life (EQ-5D), Knee injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Forgotten Joint Score (FJS) as well as 3D movement and gait analysis.
Inclusion criteria: Unilateral medial osteoarthritis of the knee (Kellgren 3b-4), aged 50 or above.
Exclusion criteria: Insufficient anterior cruciate ligament (ACL). Fixed varus deformity >10°, fixed flexion deformity >10°, flexion <100°. Previous high tibial osteotomy on the same side. Any neurological disease affecting strength or locomotion in any leg. Body mass index (BMI) >35. Rheumatoid disease. Symptomatic osteoarthritis of the contra lateral knee or any hip. Insufficient written or spoken Swedish.
- Conditions
- Knee Osteoarthritis
- Being tested
- Unicompartmental knee replacement, Total knee replacement
- Keywords
- Medial gonarthritis, knee osteoarthritis,, Muscle function, muscle mass, muscle atrophy, Total knee arthroplasty (TKA), Unicondylar knee arthroplasty (UKA), Total knee replacement (TKR), Unicondylar knee replacement (UKR), Health-related quality of life (HRQoL), Patient related outcome measurements (PROMs)
- Medical subject headings
- Osteoarthritis, Knee, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental knee replacementProcedure or surgery
Also called Oxford
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
Total knee replacementProcedure or surgery
Also called PFC
Participants with a medial gonarthritis are operated with a total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| UKA, unicompartmental knee replacement | Experimental | Procedure: Participants are operated with a mobile bearing medial unicompartmental knee arthroplasty (Oxford). They are followed with CT, functional tests and PROM, compared with those operated with TKA. Receives: Procedure: Unicompartmental knee replacement |
| TKA, total knee replacement | Experimental | Procedure: Participants are operated with a cruciate retaining conventional tricompartmental prosthesis (PFC). They are followed with CT, functional tests and PROM, compared with those operated with UKA. Receives: Procedure: Total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Thigh muscle cross sectional area and radiological attenuation measured by CT
Measured: 2 years
Secondary outcomes (3)
Muscle function
Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.
Measured: 2 years
Health related outcome measurement, questionnaire
EQ5D, a qualitative measurement of patient perceived quality of life
Measured: 2 years
Patient reported outcome measurement, knee function questionnaire (PROM).
Knee osteoarthritis outcome score (KOOS).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2022 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margareta Hedström, Karolinska Institutet
- Investigators
- Margareta Hedström, MD,PhD, Principal investigator, CLINTEC, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563756
- Sponsor's protocol ID
- UNITKAstudien2015
- Acronym
- UKA or TKA?
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2015
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
- ClinicalTrials.gov ID
- NCT02563756
- Acronym / sponsor ID
- UKA or TKA? / UNITKAstudien2015
- Conditions
- Knee Osteoarthritis
- Keywords
- Medial gonarthritis, knee osteoarthritis,, Muscle function, muscle mass, muscle atrophy, Total knee arthroplasty (TKA), Unicondylar knee arthroplasty (UKA), Total knee replacement (TKR), Unicondylar knee replacement (UKR), Health-related quality of life (HRQoL), Patient related outcome measurements (PROMs)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement.
Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome.
Detailed description
Objective: The investigators aim with the present study was to compare patient related outcome measurements, knee function and muscle mass in patients operated with an UKR or a TKR for medial gonarthritis.
Hypothesis: The investigators hypothesize that a greater number of patients might benefit from a less invasive surgery in terms of increased quality of life, function and muscle mass.
Primary Outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT.
Secondary outcomes: Functional tests (timed up and go, 30s sit and stand, forward reach, forward step down, 6 min walk and 40 m walk test), knee strength (Biodex isokinetic dynamometer) and patient reported pain on a visual analogue scale (VAS). A number of PROMs: Health related quality of life (EQ-5D), Knee injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Forgotten Joint Score (FJS) as well as 3D movement and gait analysis.
Inclusion criteria: Unilateral medial osteoarthritis of the knee (Kellgren 3b-4), aged 50 or above.
Exclusion criteria: Insufficient anterior cruciate ligament (ACL). Fixed varus deformity >10°, fixed flexion deformity >10°, flexion <100°. Previous high tibial osteotomy on the same side. Any neurological disease affecting strength or locomotion in any leg. Body mass index (BMI) >35. Rheumatoid disease. Symptomatic osteoarthritis of the contra lateral knee or any hip. Insufficient written or spoken Swedish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UKA, unicompartmental knee replacement | Experimental | Procedure: Unicompartmental knee replacementProcedure: Participants are operated with a mobile bearing medial unicompartmental knee arthroplasty (Oxford). They are followed with CT, functional tests and PROM, compared with those operated with TKA. |
| TKA, total knee replacement | Experimental | Procedure: Total knee replacementProcedure: Participants are operated with a cruciate retaining conventional tricompartmental prosthesis (PFC). They are followed with CT, functional tests and PROM, compared with those operated with UKA. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medial gonarthritis, (Kellgren 3b-4)
- correctible varus deformity less than 10 degrees
- intact ACL
- proficient in written and spoken swedish
Key exclusion criteria (6 listed)
- Valgus gonarthritis
- flexion deformity of 10 degrees
- knee flexion of less than 100 degrees
- previous high tibial osteotomy
- neuromuscular disorders of lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unicompartmental knee replacementAlso: OxfordParticipants with a medial gonarthritis are operated with a medial unicompartmental prosthesis | Procedure or surgery | UKA, unicompartmental knee replacement |
| Total knee replacementAlso: PFCParticipants with a medial gonarthritis are operated with a total knee replacement | Procedure or surgery | TKA, total knee replacement |
Primary outcome
Muscle mass
Time frame: 2 years
Thigh muscle cross sectional area and radiological attenuation measured by CT
3 secondary outcomes
Muscle function
Time frame: 2 years
Health related outcome measurement, questionnaire
Time frame: 2 years
Patient reported outcome measurement, knee function questionnaire (PROM).
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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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.
Nicolas Martinez, MD contact
Margareta Hedström, MD,PhD principal investigator
CLINTEC, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental knee replacement and Total knee replacement in people with Knee Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margareta Hedström, MD, PhD (+4670735959, margareta.hedstrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2020.