NCT04199377

Brief Summary

Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both 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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration 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

October 20, 2017

Completed
1 month 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
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

November 27, 2017

Last Update Submit

December 11, 2019

Conditions

HIP REPLACEMENTKNEE REPLACEMENT

Outcome Measures

Primary Outcomes (4)

  • HARRIS HIP SCORE

    scale range: 0-100; excellent results: 80-100

    10 years

  • KNEE SOCIETY SCORE

    scale range: 0-100; excellent results: 80-100

    10 years

  • HARRIS HIP SCORE

    scale range: 0-100; excellent results: 80-100

    5 years

  • KNEE SOCIETY SCORE

    scale range: 0-100; excellent results: 80-100

    5 years

Study Arms (1)

hip or knee replacement

EXPERIMENTAL

total hip or knee replacement

Procedure: HIP KNEE REPLACEMENT

Interventions

HIP KNEE REPLACEMENTPROCEDURE

HIP KNEE REPLACEMENT

hip or knee replacement

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures

You may not qualify if:

  • \- Patients underwent other types of knee or hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

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

October 20, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)