Research with human participants

Overview of medical research in the Netherlands

Long term follow-up of anterior cruciate ligament ruptures: bone-patellatendon-bone autograft reconstruction versus non-operative treatment.

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To study the clinical and radiological outcomes 20 years after operative or conservative treatment for an ACL rupture

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Ethical review
Not approved
Status
Will not start
Health condition type
Joint disorders
Study type
Observational invasive

ID

NL-OMON37182

Source

ToetsingOnline

Brief title

Long term results of ACL ruptures

Condition

  • Joint disorders
  • Bone and joint therapeutic procedures

Synonym

ACL; anterior cruciate ligament

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
anterior cruciate ligament, bone-patellatendon-bone reconstruction, non-operative treatment

Outcome measures

Primary outcome

1. artrosis on the x-ray of the knee

2. clinical outcome scores of knee functionality (KOOS and Lysholm) and laxity

found with physical examination

Secondary outcome

1. activity level; tegner score

2. meniscal injuries

3. the number of (re-)operations

4. correlation of artrosis of the knee with general artrosis

Background summary

We conducted a case control study in which we compared the conservative
teatment with the operative treatment for patients after an ACL rupture.(MEC
218.023/2002/227) The literature on longterm outcomes after ACL ruptures with
radiological evaluation and also conservative treatment is scarce.

Study objective

To study the clinical and radiological outcomes 20 years after operative or
conservative treatment for an ACL rupture

Study design

Long-term follow-up of a case-control study comparing operative with
conservative treatment for an ACL rupture. All patients will be asked to visit
the outpatient clinic of the orthopedics department once for radiological and
clinical evalution of the knee function.

Study burden and risks

The burden is primarly time (visit to the outpatient clinic) and radiation
(three knee x-rays and one hand x-ray). There is no direct benefit from
participation. Travel allowance will be offered to participants.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3015 CE
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3015 CE
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

All patients included in our Case-Control study (MEC 218.023/2002/227) will be invited to participate.

Exclusion criteria

Not applicable

Design

Study type :
Observational invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Will not start
Enrollment :
50
Type :
Anticipated

Not approved
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

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 NL42562.078.12