Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04378491
Other study ID # 2019-01405; ch20Muendermann2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date September 30, 2020

Study information

Verified date November 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Read more »

Locations

Country Name City State
Switzerland Orthopädie/Traumatologie, University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary (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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT05184439 - Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Terminated NCT02998372 - Computational Simulation of Patellar Instability
Completed NCT03983213 - The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.
Recruiting NCT04849130 - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation N/A
Recruiting NCT04653753 - Assessment of the Safety and Performance of a Patellofemoral Brace N/A
Recruiting NCT05029505 - The Caton-Deschamps Index Reliability in Patellar Stabilization Surgery.
Enrolling by invitation NCT02333825 - Pediatric and Adolescent Patellar Instability N/A
Terminated NCT00816647 - A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction N/A
Completed NCT04438109 - Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)
Completed NCT03304119 - Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?