Research with human participants

Overview of medical research in the Netherlands

Surgery and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomised controlled trial.

Published:
Last updated:

Zie het onderzoeksprotocol 2: "Objectives".

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruiting
Health condition type
Tendon, ligament and cartilage disorders
Study type
Interventional

ID

NL-OMON51505

Source

ToetsingOnline

Brief title

REVITALISE

Condition

  • Tendon, ligament and cartilage disorders

Synonym

Patellofemoral Pain Syndrome

Research involving

Human

Sponsors and support

Primary sponsor :
Canisius Wilhelmina Ziekenhuis
Source(s) of monetary or material Support :
CWZ Wetenschapsfonds

Intervention

Keyword :
Patello Femoral Pain Syndorme, Tibial Tubercle Transfer

Outcome measures

Primary outcome

Zie het onderzoeksprotocol 7.1.1: "Main study parameter/endpoint"

Secondary outcome

Zie het onderzoeksprotocol 7.1.2: "Secondary study parameters/endpoints "

Background summary

Zie het onderzoeksprotocol 1:"Introduction and rationale".

Study objective

Zie het onderzoeksprotocol 2: "Objectives".

Study design

Zie het onderzoeksprotocol 3: "Study protocol"

Intervention

Zie het onderzoeksprotocol 5.1: "Investigational product/treatment"

Study burden and risks

Zie het onderzoeksprotocol 10.4: "Benefits and risks assessment, group
relatedness "
The risk score of the study is classified low (*verwaarloosbaar risico*),
according to the *Nederlandse Federatie van Universitair Medische Centra:
*Richtlijn Mensgebonden Onderzoek (versie 2020)*.

Public
Canisius Wilhelmina Ziekenhuis

Weg door Jonkerbos 100
Nijmegen 6532SZ
NL
Scientific
Canisius Wilhelmina Ziekenhuis

Weg door Jonkerbos 100
Nijmegen 6532SZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)

Inclusion criteria

Zie 4.2: "Inclusion criteria" in het onderzoeksprotocol.

Exclusion criteria

Zie 4.3: "Exclusion criteria" in het onderzoeksprotocol.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
40
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL80956.091.22