To compare two revalidation protocols with reference to the ACL reconstruction
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Tegner knee score
2. Lysholm knee score
3. IKDC knee score
4. VAS score for pain
Secondary outcome
Return to the previous level of functioning (work, ADL activities)
Background summary
The subject of interest in this study is the revalidation after ACL
reconstruction. Originally, the operation was followed by a long period of
revalidation on an inpatient basis. Nowadays patients are dismissed from the
hospital earlier or the operation is performed on an outpatient basis. In this
situation the revalidation supervised by the physical therapist is started
directly after the operation. In the literature no differences are reported
between inpatient or outpatient patient groups with reference to function, time
of recovery and pain reported by the patient.
Study objective
To compare two revalidation protocols with reference to the ACL reconstruction
Study design
Mono centre study design (Red Cross Hospital, Beverwijk, the Netherlands)
Prospective
Open study design
To compare two patient groups after ACL reconstruction. Randomisation for one
of the two revalidation protocols. In the first protocol the operation is
performed on an inpatient basis with 3 to 5 days of inpatient revalidation
under supervision by the physical therapist. After this inpatient period, the
revalidation is continued on an outpatient basis. In the second protocol the
patient is operated in an outpatient setting followed by outpatient
revalidation for the moment of operation.
Intervention
To compare two patient groups after ACL reconstruction. Randomisation for one
of the two revalidation protocols. In the first protocol the operation is
performed on an inpatient basis with 3 to 5 days of inpatient revalidation
under supervision by the physical therapist. After this inpatient period, the
revalidation is continued on an outpatient basis. In the second protocol the
patient is operated in an outpatient setting followed by outpatient
revalidation for the moment of operation.
Study burden and risks
Low burden associated with participation. There will be no extra (outpatient)
controls other than normal for this operation (2 weeks, 6 weeks, 3 months, 6
months and one year postoperative). During each outpatient control
questionnaires will be used to assess the progress of the patient. This will
take approximately 10 minutes extra.
In the literature reports are made of the same risks for inpatient and
outpatient operated and revalidated patients.
Vondellaan 13
1942 LE Beverwijk
NL
Vondellaan 13
1942 LE Beverwijk
NL
Listed location countries
Age
Inclusion criteria
Patient with functional complaints of a ruptured anterior cruciate ligament. Able to give informed consent and able to fill in the questionnaires.
Exclusion criteria
open epiphysis of proximal tibia or distal femur
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 | NL22881.094.08 |