NCT02563756

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

7 years

First QC Date

September 18, 2015

Last Update Submit

October 23, 2020

Conditions

Knee Osteoarthritis

Keywords

Medial gonarthritis, knee osteoarthritis,Muscle function, muscle mass, muscle atrophyTotal 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)

Outcome Measures

Primary Outcomes (1)

  • Muscle mass

    Thigh muscle cross sectional area and radiological attenuation measured by CT

    2 years

Secondary Outcomes (3)

  • Muscle function

    2 years

  • Health related outcome measurement, questionnaire

    2 years

  • Patient reported outcome measurement, knee function questionnaire (PROM).

    2 years

Study Arms (2)

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.

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.

Procedure: Total knee replacement

Interventions

Unicompartmental knee replacementPROCEDURE

Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis

Also known as: Oxford
UKA, unicompartmental knee replacement
Total knee replacementPROCEDURE

Participants with a medial gonarthritis are operated with a total knee replacement

Also known as: PFC
TKA, total knee replacement

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeMuscular Atrophy

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Margareta Hedström, MD,PhD

    CLINTEC, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margareta Hedström, MD, PhD

CONTACT

+4670735959margareta.hedstrom@ki.se

Nicolas Martinez, MD

CONTACT

+46709900089

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2022

Study Completion

September 1, 2025

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations

SE(1)