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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Unicompartmental knee replacement
Total knee replacement
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring 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)

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UKA, unicompartmental knee replacement

TKA, total knee replacement

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

Muscle mass
Thigh muscle cross sectional area and radiological attenuation measured by CT

Secondary Outcome Measures

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.
Health related outcome measurement, questionnaire
EQ5D, a qualitative measurement of patient perceived quality of life
Patient reported outcome measurement, knee function questionnaire (PROM).
Knee osteoarthritis outcome score (KOOS).

Full Information

First Posted
September 18, 2015
Last Updated
October 23, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02563756
Brief Title
Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass
Acronym
UKA or TKA?
Official Title
Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UKA, unicompartmental knee replacement
Arm Type
Experimental
Arm Description
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.
Arm Title
TKA, total knee replacement
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Unicompartmental knee replacement
Other Intervention Name(s)
Oxford
Intervention Description
Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
Intervention Type
Procedure
Intervention Name(s)
Total knee replacement
Other Intervention Name(s)
PFC
Intervention Description
Participants with a medial gonarthritis are operated with a total knee replacement
Primary Outcome Measure Information:
Title
Muscle mass
Description
Thigh muscle cross sectional area and radiological attenuation measured by CT
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Muscle function
Description
Functional test of quadriceps strength, a stair negotiation test where the patient is asked to perform as many repetitions as possible in 30 seconds.
Time Frame
2 years
Title
Health related outcome measurement, questionnaire
Description
EQ5D, a qualitative measurement of patient perceived quality of life
Time Frame
2 years
Title
Patient reported outcome measurement, knee function questionnaire (PROM).
Description
Knee osteoarthritis outcome score (KOOS).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margareta Hedström, MD, PhD
Phone
+4670735959
Email
margareta.hedstrom@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Martinez, MD
Phone
+46709900089
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Hedström, MD,PhD
Organizational Affiliation
CLINTEC, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Aulin, MD
Email
carl.aulin@karolinska.se
First Name & Middle Initial & Last Name & Degree
Nicolas Martinez, MD
Phone
+46709900089
Email
nicolas.martinez-carranza@karolinska.se

12. IPD Sharing Statement

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Unicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass

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