Evaluate pre- and postoperative reported outcomes in patients receiving a primary isolated soft-tissue loop MPFL reconstruction for the treatment of patellar instability. Additionally, it is aimed to investigate the difference in patella tracking…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the pre- and postoperative difference in patient
reported outcome measures (PROMs).
PROMs: KOOS-PS, Kujala kniescore, EQ5D-5L and BPII
Secondary outcome
Difference between pre-operative and one post-operative in patellar tracking,
measured with 4DCT. This will be measured before and 12 months after the
operation.
Background summary
A patellar dislocation is one of the most common acute knee disorders in
children and adolescents, causing pain and functional decline. In order to
restore healthy kinematics and relieve pain, patients can receive a MPFL
reconstruction. Still, there is no consensus on the ideal MPFL reconstruction
method and many different variations exist. For a reliable comparison, each
MPFL reconstruction method should be evaluated clinically. Within the
Radboudumc, a dynamic soft-tissue loop method is used for MPFL reconstruction.
The method has not yet been evaluated clinically, and the difference in patella
tracking is largely unknown.
For a comprehensive description of the background, see section 1 of the
research protocol.
Study objective
Evaluate pre- and postoperative reported outcomes in patients receiving a
primary isolated soft-tissue loop MPFL reconstruction for the treatment of
patellar instability. Additionally, it is aimed to investigate the difference
in patella tracking before and 12 months after surgery measured with 4D CT
imaging.
Study design
Prospective single centre observational study
Intervention
n.v.t.
Study burden and risks
CT scans exposes patients to radiation. For this study the level of radiation
is estimated as an negligible risk. No additional risks are associated with
this study. Potential burdens for patients are predominantly time and
additional radiation exposure.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• Age of 16 years and older.
• Recurrent patellofemoral instability, for which:
1) the patient will receive a primary isolated MPFL reconstruction, or
2) the patient has received a primary isolated MPFL reconstruction <12 months
ago, on the condition that the patient has completed his/her questionnaires and
received a usable preoperative 4D CT scan .
• Informed consent of the patient.
Exclusion criteria
• Patients below an age of 16 years.
• Patients that are pregnant.
• BMI > 35
• Patients that are unable to actively flex and extend their knee.
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 |
|---|---|
| ClinicalTrials.gov | NCT05547269 |
| CCMO | NL82266.091.22 |