Conservative versus arthroscopic refixation of the Medial PatelloFemoral Ligament (MPFL) after traumatic first time dislocation of the patella in children

ISRCTN ISRCTN39959729
DOI https://doi.org/10.1186/ISRCTN39959729
Secondary identifying numbers N/A
Submission date
25/02/2011
Registration date
31/05/2011
Last edited
31/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Per-Mats Janarv
Scientific

Department of Pediatric Orthopedics
Astrid Lindgren Children's Hospital
Karolinska University Hospital
Stockholm
17176
Sweden

Study information

Study designProspective single-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleConservative versus Arthroscopic refixation of the Medial Patellofemoral ligament (MPFL) after traumatic first time dislocation of the patella in children: a prospective randomised study
Study objectivesArthroscopic repair of the MPFL in the acute phase will decrease the redislocation rate compared to conservative treatment with an orthosis.
Ethics approval(s)The regional Ethics board in Stockholm; D-number: 2008/232-31/4 approved on 5th March 2008 and D-number 2009/1440-32 approved on 17th September 2009
Health condition(s) or problem(s) studiedDislocation of patella in children
Intervention1. The patients will be randomised either to conservative (orthosis) treatment or arthroscopic refixation of the MPFL with the use of anchors
2. The randomisation is made directly after the diagnostic arthroscopy with the patient still under general anesthesia
3. In patients who are randomised to the surgical group, the operation will continue with the arthroscopic repair of the MPFL
4. The aim of this study is to compare the redislocation rate after traumatic first time patellar dislocation between conservative treatment with orthosis for 4 weeks and the new arthroscopic procedure with acute repair of the MPFL injury followed by 4 weeks in plaster
5. All patients will have an MRI and diagnostic arthroscopy within two weeks after the trauma
6. If the arthroscopic findings (MPFL lesion) is the same as the MRI they are randomised on the operating table in the above mentioned two treatment groups
7. The surgical group will continue the arthroscopy with refixation of the MPFL with anchors 8. Both groups will receive physiotherapy until they have regained knee function
9. The follow-up period will be 2 years after arthroscopy
Intervention typeMixed
Primary outcome measure1. The patients are followed continuously 2 years after arthroscopy at our outpatient clinic
2. If they have any problems with their knee during the study period or redislocation they are advised to contact us for help
3. We will do a physical and radiological examination to confirm the diagnosis and the clinical findings will be documented in the medical casebook
4. The primary outcome is redislocation rate of the patella compared between the two groups under these 2 years
Secondary outcome measures1. Post-operative complications, knee- examination, joint motion, patient administrated scores to evaluate activity, subjective knee function (Lysholm, Tegner score, KOOS-child and Kujala score) and quality of life for children (EQ-5D-Y)
1.1. Kujala score, which is a 13-item questionnaire with discrete categories related to various levels of knee function. Categories within each item are weighted and responses are summarised to provide an overall index in which 100 represents no disability. Among other things, the questionnaire evaluates pain or disability related to the loading of the patellofemoral joint during sitting, walking, running, jumping, and stair climbing. (Kujala et al. Scoring of patellofemoral disorders. Arthroscopy 1993;9:159-63). Previous authors have also termed the score 'the Anterior Knee Pain Scale (AKPS)'.
1.2. The Lysholm score and Tegner activity scale are commonly used to document outcomes after arthroscopic knee surgery. These outcomes measurements are subjective in nature, and they evaluate performance and activity restrictions both before and after surgery, making them a valuable research tool when judging the effectiveness of surgical treatment. Lysholm score. Am J Sports Med. 2003 Jul-Aug; 31(4):487-92. Tegner activity scale from 0-10 Clin. Orthop. Relat. Res. 1985 Sep; 198(198):43-9.
1.3. Knee Osteoarthritis Outcome score (KOOS) is developed as an instrument to assess the patient’s opinion about knee function and associated problems (the child version is on its way to be validated).
1.4. Health and Quality of Life Outcomes 2003, 1:64. The newly developed EQ-5D-Y is a useful tool to measure health related quality of life in young people in an age appropriate manner. Springerlink.com ; Qual Life Res (2010) 19:875–886
1.5. Objective knee function is measured with hop-tests and “kneebending/30s-test”. Visual analog scales (VAS) are used to assess activity related pains. The outcome will also be correlated to predisposing factors such as Q-angel/TT-TG distance, patella alta, patellar tilt, trochlea dysplasia, and joint mobility according to the Beighton score.
Overall study start date09/12/2009
Completion date30/04/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit9 Years
Upper age limit14 Years
SexBoth
Target number of participants64 patients
Key inclusion criteria1. Children 9-14 years of age
2. Admitted to the emergency room (ER) with haemartrosis after a traumatic first time patellar dislocation
3. The diagnosis is based on clinical examination, magnetic resonance imaging (MRI) and arthroscopy
4. The arthroscopy is the final confirmation of the diagnosis, and it gives a detailed description of the MPFL injury and possible ostechondral lesions
5. Prior to the arthroscopy, the patients are asked to participate in the study
6. The patients who have given informed consent
Key exclusion criteria1. Previous significant injury to the same knee including patellar dislocation, systemic joint disease or syndromes affecting the knee joint
2. Osteochondral lesion > 1cm on weight bearing area that needs open reduction and fixation
Date of first enrolment09/12/2009
Date of final enrolment30/04/2012

Locations

Countries of recruitment

  • Sweden

Study participating centre

Astrid Lindgren Children's Hospital
Stockholm
17176
Sweden

Sponsor information

Capio Research Foundation (Sweden)
Research organisation

Box 8173
Stockholm
10420
Sweden

ROR logo "ROR" https://ror.org/04ge4r742

Funders

Funder type

Hospital/treatment centre

Department of Pediatric Orthopedics, Karolinska University Hospital (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2018 Yes No

Editorial Notes

31/05/2018: Publication reference added.