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

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.

Study Overview

• Status: Completed
• Conditions: Patellar Instability
• Intervention / Treatment: Other: Collection of clinical measurements; Other: Collection of data for muscle strength; Other: Collection of EMG Data; Other: Collection of Clinical Scores; Other: Collection of Imaging Data - Radiological measurements

Detailed Description

A short lateral articular trochlea leads to failure in stabilizing the patella close to full Extension of the knee. To address this type of pathology, a trochlear lengthening osteotomy was described. To date only case reports describing the clinical outcome of this new osteotomy exist and information on functional outcome regarding muscle strength and electromyography (EMG) data is lacking. 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.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Orthopädie/Traumatologie, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 2 years (as of September 2019) since conducting a lateral trochlear lengthening osteotomy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Evaluation of the outcome of the operation	The patients will be asked to subjectively evaluate the outcome of the operation according to the following options: Excellent: Patient is fully recovered and has resumed all activity without restrictions; Somewhat Improved: Patient is mostly recovered and has resumed a majority of activities; Unchanged: Patient outcome is equivalent to pre-operative complaints; Somewhat Worse: Patient is experiencing symptoms worse than pre-operative complaints; Significantly Worse: Patient outcome is worse than pre-operative complaints with significantly worse symptoms	at Baseline
Kujala Anterior Knee Pain Scale (AKPS)	The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). Total scores range from 0 to 100.	at Baseline
Lysholm Knee Score	The Lysholm Knee Score consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.	at Baseline
Visual analog scale score (VAS)	The visual analogue scale (VAS) is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable.	at Baseline
Tegner activity scale	The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.	at Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: +41 (0)61 32 87133 Muendermann, Prof., Orthopädie/Traumatologie, University Hospital Basel

Publications and helpful links

General Publications

• Ismailidis P, Egloff C, Nüesch C, Mündermann 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: lengthening osteotomy of the lateral trochlea; Lateral trochlear lengthening osteotomy; trochlear dysplasia Dejour type A or B; short lateral articular trochlea
• Other Study ID Numbers: 2019-01405; ch20Muendermann2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No