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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

Tracking Information
First Submitted Date  ICMJE September 18, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date November 1, 2018
Actual Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
Muscle mass [ Time Frame: 2 years ]
Thigh muscle cross sectional area and radiological attenuation measured by CT
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Patient reported outcome measurement, knee function questionnaire (PROM). [ Time Frame: 2 years ]
    Knee osteoarthritis outcome score (KOOS).
  • Muscle mass [ Time Frame: 2 years ]
    Cross-sectional area of muscle groups at three different levels in the hip, thigh and calf muscles.
  • Muscle quality [ Time Frame: 2 years ]
    Muscle density, using computerized tomography (CT), hounsfield units as a measurement of fat infiltration indicative of muscle atrophy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
  • 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.
  • Health related outcome measurement, questionnaire [ Time Frame: 2 years ]
    EQ5D, a qualitative measurement of patient perceived quality of life
  • Patient reported outcome measurement, knee function questionnaire (PROM). [ Time Frame: 2 years ]
    Knee osteoarthritis outcome score (KOOS).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • 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.
  • Health related outcome measurement, questionnaire [ Time Frame: 2 years ]
    EQ5D, a qualitative measurement of patient perceived quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
Official Title  ICMJE Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Unicompartmental knee replacement
    Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
    Other Name: Oxford
  • Procedure: Total knee replacement
    Participants with a medial gonarthritis are operated with a total knee replacement
    Other Name: PFC
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Unicompartmental knee replacement
  • 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.
    Intervention: Procedure: Total knee replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margareta Hedström, MD, PhD +4670735959 margareta.hedstrom@ki.se
Contact: Nicolas Martinez, MD +46709900089
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563756
Other Study ID Numbers  ICMJE UNITKAstudien2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margareta Hedström, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margareta Hedström, MD,PhD CLINTEC, Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP