The primary objective of the present study is to determine the long-term effect of ACL reconstruction on the knee joint range of motion, stability and the incidence of osteoarthritis. Secondary we will investigate the long-term effects on the…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiographic outcome measures
• Evidence of osteoarthritis based on Kellgren-Lawrence scale
Clinical outcome measures
• Range of Motion
• Knee stability
Secondary outcome
• Quality of Life
• Pain
• Status of return to work and daily activities
• Secondary surgical procedures
• Surgical complication
• Patient characteristics
Background summary
The anterior cruciate ligament (ACL) is of high importance in stabilizing the
healthy knee. Rupture of this ligament has a high incidence in the young and
active population and, when left untreated, can result in present instability
of the knee, inability to return to full activity, meniscal tears, and
articular cartilage damage. The utilization of operative reconstruction is
therefore generally accepted. ACL reconstruction surgical techniques have
undergone many developments over the past decades. Many reconstruction
techniques have been applied over the past decades.
Several variable methods have been used to reconstruct a torn ACL. In terms of
femoral fixation the graft can be suspensory fixed, joint line fixation
transfemoral fixation. Furthermore, varieties are possible in graft choice. The
most commonly used autografts in ACL reconstruction are the patellar tendon
(PT) autograft and the hamstring tendon (HS) autograft. Each method has its own
specific advantages, but also complications have been described.
Many studies have reported the short en midterm results after ACL
reconstruction. However, studies with long term follow-up (>=15 years) remain
rare. Since progressive degenerative changes may develop over time it is
important to evaluate the long-term results after ACL reconstruction.
We hypothesize that there will be no difference in degenerative changes,
function and stability of the ACL reconstructed (ACL-r) knee in comparison with
the contralateral knee. Furthermore we hypothesis that there will be more
generative changes in patients with higher age and BMI at time of surgery.
Study objective
The primary objective of the present study is to determine the long-term effect
of ACL reconstruction on the knee joint range of motion, stability and the
incidence of osteoarthritis. Secondary we will investigate the long-term
effects on the quality of life and whether personal characteristics like age,
gender and body mass index (BMI) and time to surgery are predictive for the
degenerative changes of the knee joint.
Study design
Prospective longitudinal cohort study
Study burden and risks
Included patients will undergo additional physical and radiological
examination. Some may find an additional check-up to be a benefit. The time (60
minutes) and radiation burden for the subjects are small, and in proportion to
the potential value of the research, as no long term results of this surgical
procedure are presently known. All patients included in this study will undergo
radiographic assessment, which means two radiographs will be performed per knee
that the patient otherwise would not have undergone. The mean radiation
exposure during one radiograph of the knee is 0,01 mSv (milliSievert). Thus,
each patient is exposed to 0,04 mSv. For comparison: background radiation
exposure in the Netherlands is around 2 mSv per year.
Wilhelminalaan 12
ALKMAAR 1815JC
NL
Wilhelminalaan 12
ALKMAAR 1815JC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;• Unilateral ACL rupture;
• Suitable to one of the subgroups;
• Can be contacted;
• Are willing and able to participate in the study protocol and follow-up visitation of the outpatient clinic
Exclusion criteria
Subjects will be excluded when they:;• are not willing to participate;
• are not capable of participating (either mentally or physically);
• have deceased;
• are unable to undergo radiography (e.g. due to pregnancy).
Design
Recruitment
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 | NL51900.094.15 |