NCT04378491

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

April 29, 2020

Last Update Submit

November 9, 2020

Conditions

Keywords

lengthening osteotomy of the lateral trochleaLateral trochlear lengthening osteotomytrochlear dysplasia Dejour type A or Bshort lateral articular trochlea

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Interventions

Muscle Strength

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • +41 (0)61 32 87133 Muendermann, Prof.

    Orthopädie/Traumatologie, University Hospital Basel

    PRINCIPAL INVESTIGATOR

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

Locations