NCT04198389

Brief Summary

Retrospective evaluation of: Functional results Clinical results Survivorship of knee replacement performed with small implants, isolated or combined

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
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

July 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

4.5 years

First QC Date

November 27, 2017

Last Update Submit

December 11, 2019

Conditions

KNEE REPLACEMENT

Outcome Measures

Primary Outcomes (3)

  • KNEE SOCIETY SCORE

    total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100

    2 years

  • KNEE SOCIETY SCORE

    total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100

    5 years

  • KNEE SOCIETY SCORE

    total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100

    10 years

Study Arms (1)

partial knee replacement

EXPERIMENTAL

medial UNI, lateral UNI, patellofemoral replacement, combined UNI+ patellofemoral replacement, combined medial and lateral UNI

Procedure: PARTIAL KNEE REPLACEMENT

Interventions

PARTIAL KNEE REPLACEMENTPROCEDURE

PARTIAL KNEE REPLACEMENT

partial knee replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving medial UNI or lateral UNI or patellofemoral replacement or combined UNI+ patellofemoral replacement or combined medial and lateral UNI
  • age \> 18 years

You may not qualify if:

  • patients receiving total knee replacement
  • patients having revision or a knee replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Related Publications (1)

  • Romagnoli S, Vitale JA, Marullo M. Outcomes of lateral unicompartmental knee arthroplasty in post-traumatic osteoarthritis, a retrospective comparative study. Int Orthop. 2020 Nov;44(11):2321-2328. doi: 10.1007/s00264-020-04665-z. Epub 2020 Jun 20.

    PMID: 32561964DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 13, 2019

Study Start

July 20, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)