Range-of-motion Analysis of Reverse Shoulder Arthroplasty

Shoulder Impingement Clinical Trial

— ROM  

Official title:

Range of Motion Analysis for the Optimization of Reverse Shoulder Arthroplasty Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633083
• Other study ID #: S62153
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: March 8, 2023

Study information

• Verified date: September 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Limited range-of-motion (ROM) is a common problem after reverse shoulder arthroplasty (RSA). The occurrence and magnitude depend on both surgical and patient-related factors. The most important surgical factor is the occurrence of impingement, which implicates collision between the humeral implant or bone and the scapula, limiting further motion. Patient-related factors such as scapula geometry and muscle function and activation also play an important role. Surgeons have to account for these factors when planning and implanting a RSA. Software models can support the surgeon during preoperative planning by using imaging data to simulate the ROM of a patient's shoulder after RSA. These software models allow for adaptation of the implant position during preoperative planning and, by this optimize the postoperative ROM. However, the models currently developed are limited in terms of ROM simulation and the factors the models take into account.

Description:

The impingement-free ROM in a RSA patient is defined as the rotational area the humeral liner can move through without colliding against the scapula or dislocating the joint. In a previous study, a new software model was developed that uses imaging data to compute and quantify the impingement-free ROM of a patient according to clinically relevant motions. Before this model can be used in clinical practice, a validation of the model's accuracy in predicting real RSA patient outcomes is required. Therefore, the first objective is to verify the model's ability to predict the ROM of the glenohumeral joint in real RSA patients. The investigators will investigate and quantify the ROM and joint angles of RSA patients with and without impingement with the help of EOS imaging and video motion analysis. The investigators can then compare model outputs with measured patient outcomes. Additionally, the investigators will investigate how well our software model can predict impingement in patients with known postoperative impingement.

Currently, the software model uses a database of healthy shoulder kinematic motions to produce an objective ROM score for a RSA. However, it is not known if healthy shoulder kinematics are a suitable reference for quantifying and interpreting RSA kinematics. Glenohumeral motions of healthy subjects are already extensively described by Ludewig et al. Glenohumeral motions of RSA patients are not yet reported. Also, little is known about muscle activation patterns in RSA patients. The second objective is to describe muscle activation patterns and shoulder kinematics of RSA patients and compare our measured RSA kinematic motions to the healthy kinematic motion data currently used in the software model. Therefore, the investigators will perform instrumented 3D motion analysis in conjunction with electromyography measurements to incorporate muscle activation patterns into our RSA glenohumeral motion analysis. Our additional sub-objective is to compare muscle activation patterns between patients with and without limited ROM, with the goal of identifying differences between the two groups.

The third objective is to identify patient-related and implant related factors that influence the ROM after a reversed shoulder arthroplasty. Therefore, the investigators will investigate clinical factors that could have effect on the ROM after RSA. The different factors (sex, birth year, Body Mass Index, generic score EQ-5D-3L, Tampa Schaal voor kinesofobia) will be analyzed both across and within patients with and without limited ROM with the goal of identifying their relation to ROM. The most important implanted related factor will also be investigated and analyzed both across and within groups: implant position in terms of glenoid component version, inclination and location of center of rotation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with RSA operated in the University Hospitals Leuven, Belgium

• Ability and willingness of patient to attend follow-up visit and complete patient questionnaires

• Complete patient informed consent

• Preoperative CT-scan available

• Pain free RSA (VAS score = 3) more than 1 year postoperative

Exclusion Criteria:

• Only RSA patients with a functional RSA will be included, so patients with postoperative stiffness, pain, instability or pseudoparalysis will be excluded.

Related Conditions & MeSH terms

• Shoulder Impingement
• Shoulder Impingement Syndrome

Intervention

Other:
• Data collection
Clinical Data: Registration of patient identity, sex and birth year, Body Mass Index, generic score EQ-5D-3L, Tampa Schaal voor kinesofobia and shoulder specific score like Constant Score, PROMS, ADLER, SST and postoperative ROM. Imaging Data: A preoperative and postoperative CT scan and 1-year postoperative radiograph (all three part of standard clinical practice) will be obtained. This data is used to extract the bone geometries and implant position. Movement Analysis: The subject should stand still followed by different motion tasks in the gait lab with collection of shoulder girdle kinematics and kinetics using a 14-camera VICON System. Stereo Radiographic EOS Measurements: Every subject included in the study will undergo a stereo radiographic EOS exam while quite standing with their arm in various positions (van Andel et al., 2008) . ROM simulation: With the developed ROM software, we will simulate the ROM of the 2 patient groups based on the available CT scan data.

Locations

Country	Name	City	State
Belgium	UZ Leuven, campus Pellenberg	Pellenberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic data (Sex)	Sex	1-time assessment at a time of 1 or more years postoperatively
Primary	Demographic data (Birth year)	Birth year	1-time assessment at a time of 1 or more years postoperatively
Primary	Demographic data (Body Mass Index)	Body Mass Index in kg/m2 (physiological parameter)	1-time assessment at a time of 1 or more years postoperatively
Primary	Demographic data (Range of motion)	Range of motion in degrees (physiological parameter)	1-time assessment at a time of 1 or more years postoperatively
Primary	Imaging data	Pre- and post-surgery CT scan	1-time assessment at a time of 1 or more years postoperatively
Primary	Movement analysis	The subject should stand still followed by different motion tasks in the gait lab with collection of shoulder girdle kinematics and kinetics using a 14-camera VICON System	1-time assessment at a time of 1 or more years postoperatively
Primary	Stereo Radiographic EOS Measurements	Every subject included in the study will undergo a stereo radiographic EOS exam while quite standing with their arm in various positions (van Andel et al., 2008)	1-time assessment at a time of 1 or more years postoperatively
Primary	ROM simulation	Simulate the ROM of the 2 patient groups based on the available CT scan data	1-time assessment at a time of 1 or more years postoperatively
Primary	EQ-5D-3L questionnaire	It is a questionnaire to measure health-related quality of life	1-time assessment at a time of 1 or more years postoperatively
Primary	Tampa scale for kinesiophobia (fear of movement)	It is a questionnaire that gives an impression of the degree of pain-related fear in patients with low back pain (LBP) or fibromyalgia.	1-time assessment at a time of 1 or more years postoperatively
Primary	Constant Score	These parameters define the level of pain and the ability to carry out the normal daily activities of the patient	1-time assessment at a time of 1 or more years postoperatively
Primary	ADLER (Activities of Daily Living [ADL] which require active External Rotation [ER])	It measures the severity of the potential handicap	1-time assessment at a time of 1 or more years postoperatively
Primary	SST (Simple Shoulder Test)	It is a measuring instrument that measures the functional limitations of the affected shoulder of patients with shoulder complaints	1-time assessment at a time of 1 or more years postoperatively