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Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass (UKA or TKA?)

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ClinicalTrials.gov Identifier: NCT02563756
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Margareta Hedström, Karolinska Institutet

Brief 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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Unicompartmental knee replacement Procedure: Total knee replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: UKA, unicompartmental knee replacement
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.
Procedure: Unicompartmental knee replacement
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
Other Name: Oxford

Experimental: TKA, total knee replacement
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.
Procedure: Total knee replacement
Participants with a medial gonarthritis are operated with a total knee replacement
Other Name: PFC




Primary Outcome Measures :
  1. Muscle mass [ Time Frame: 2 years ]
    Thigh muscle cross sectional area and radiological attenuation measured by CT


Secondary Outcome Measures :
  1. Muscle function [ Time Frame: 2 years ]
    Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.

  2. Health related outcome measurement, questionnaire [ Time Frame: 2 years ]
    EQ5D, a qualitative measurement of patient perceived quality of life

  3. Patient reported outcome measurement, knee function questionnaire (PROM). [ Time Frame: 2 years ]
    Knee osteoarthritis outcome score (KOOS).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medial gonarthritis, (Kellgren 3b-4)
  • correctible varus deformity less than 10 degrees
  • intact ACL
  • proficient in written and spoken swedish

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563756


Contacts
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Contact: Margareta Hedström, MD, PhD +4670735959 margareta.hedstrom@ki.se
Contact: Nicolas Martinez, MD +46709900089

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Carl Aulin, MD       carl.aulin@karolinska.se   
Contact: Nicolas Martinez, MD    +46709900089    nicolas.martinez-carranza@karolinska.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Margareta Hedström, MD,PhD CLINTEC, Karolinska Institutet
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Responsible Party: Margareta Hedström, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02563756    
Other Study ID Numbers: UNITKAstudien2015
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Keywords provided by Margareta Hedström, Karolinska Institutet:
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)
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases