Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy Lateral Trochlear Lengthening Osteotomy
Tro_Le_Tomy
Tro_Le_Tomy - Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy
1 other identifier
observational
6
1 country
1
Brief Summary
The purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia Dejour type A or B, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedNovember 10, 2020
November 1, 2020
6 months
April 29, 2020
November 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
presence of a recurrent patellar dislocation/ radiological reduction of the trochlear bump postoperative by plain radiograph of the knee/ lateral view
presence of a recurrent patellar dislocation postoperative by plain radiograph of the knee/ lateral view: * crossing sign: The sign is positive when the trochlear groove lies in same plane as anterior border of lateral condyle. It represents a flattened trochlear groove * double contour sign: The sign is positive when the anterior border of lateral condyle lies anterior to anterior border of medial condyle. It represents a convex trochlear groove/hypoplastic medial condyle * presence of a lateral trochlear bump prominence * the patellar height will be evaluated according to Insall-Salvati method (normal between 0.8 and 1.2) and Caton Deschamps method (normal between 0.6 and 1.3)
at Baseline
presence of a recurrent patellar dislocation/ radiological reduction of the trochlear bump postoperative by Skyline patellar view
The trochlea form will be assessed, the existence of trochlear dysplasia will be confirmed and classified according to Dejour
at Baseline
(Change in) Lateral condyle index assessed by MRI of the knee
Lateral condyle index assessed by MRI of the knee (preoperative (always conducted) and in the cases where they are available postoperative MRIs). The lateral condyle index was designed to measure the lateral trochlea by comparing the anterior cartilaginous trochlea (a) and the posterior aspect (p) \[(a:p)× 100\].
at Baseline
Secondary Outcomes (5)
Subjective Evaluation of the outcome of the operation
at Baseline
Kujala Anterior Knee Pain Scale (AKPS)
at Baseline
Lysholm Knee Score
at Baseline
Visual analog scale score (VAS)
at Baseline
Tegner activity scale
at Baseline
Interventions
Collection of clinical measurements: * Active and passive range of motion (ROM) of the knee, hip and ankle Joint bilaterally. * Passive patellar translation in 30° of flexion billaterally in quadrants of translation. * Patellar apprehension test (Fairbank's Test) and the Moving Patellar Apprehension (MPAT) test for the diagnosis of patellar instability. The Fairbank's Test is performed in 30° of Flexion while the MPAT is performed while flexing the knee from 0° to 90°.
Collection of data for muscle strength: * Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). For the knee, maximum isokinetic Flexion and extension torques will be collected between full extension and full flexion at a movement speed of 60°/s (3 x 5 repetitions) Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight
Collection of EMG Data: * Surface electrodes will be placed bilaterally on the vastus medialis and lateralis rectus femoris, biceps femoris and semitendinosus muscles following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Simultaneously with the muscle strength measurements, EMG data will be collected using a 12-channel EMG system (myon AG, Schwarzenberg, Switzerland, sampling rate 2400 Hz).
Collection of Clinical Scores: * patient's pain, range of motion and ability to perform daily living activities will be assessed using the Kujala Anterior Knee Pain Scale, Lysholm Knee Score, visual analog scale score (VAS) and the Tegner Activity Score
Collection of Imaging Data - Radiological measurements: Xrays and MRIs which were already performed as part of the original diagnostic and follow-up procedures pre- and postoperative will be reviewed and analysed.
Eligibility Criteria
All patients treated between 01/2014 and 09/2017 (n=6) with lateral trochlear lengthening osteotomy at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel
You may qualify if:
- years (as of September 2019) since conducting a lateral trochlear lengthening osteotomy
You may not qualify if:
- Inability to provide informed consent
- Neurological disorders potentially affecting lower extremity muscle strength.
- Surgery involving the patellofemoral joint prior to the lateral trochlear lengthening osteotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopädie/Traumatologie, University Hospital Basel
Basel, 4031, Switzerland
Related Publications (1)
Ismailidis P, Egloff C, Nuesch C, Mundermann A, Pagenstert G. Lateral trochlear lengthening osteotomy. Arch Orthop Trauma Surg. 2021 Oct;141(10):1721-1730. doi: 10.1007/s00402-020-03736-5. Epub 2021 Feb 24.
PMID: 33625541DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
+41 (0)61 32 87133 Muendermann, Prof.
Orthopädie/Traumatologie, University Hospital Basel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 7, 2020
Study Start
April 1, 2020
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
November 10, 2020
Record last verified: 2020-11