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Range-of-motion Analysis of Reverse Shoulder Arthroplasty (ROM)

Primary Purpose

Shoulder Impingement

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Data collection
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Impingement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ Leuven, campus Pellenberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Signs of impingement

No Signs of impingement

Arm Description

a. non- limited ROM i. Endorotation control until lumbosacral level ii. Scapular plane abduction above 150° b. limited ROM i. Endorotation control lower then lumbosacral level ii. Scapular plane abduction under 150° Intervention: clinical data, imaging data, movement analysis, EOS measurements, ROM simulation

a. non- limited ROM i. Endorotation control until lumbar level ii. Scapular plane abduction above 150° b. limited ROM i. Endorotation control lower then lumbar level ii. Scapular plane abduction under 150° Intervention: clinical data, imaging data, movement analysis, EOS measurements, ROM simulation

Outcomes

Primary Outcome Measures

Demographic data (Sex)
Sex
Demographic data (Birth year)
Birth year
Demographic data (Body Mass Index)
Body Mass Index in kg/m2 (physiological parameter)
Demographic data (Range of motion)
Range of motion in degrees (physiological parameter)
Imaging data
Pre- and post-surgery CT scan
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
Simulate the ROM of the 2 patient groups based on the available CT scan data
EQ-5D-3L questionnaire
It is a questionnaire to measure health-related quality of life
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.
Constant Score
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient
ADLER (Activities of Daily Living [ADL] which require active External Rotation [ER])
It measures the severity of the potential handicap
SST (Simple Shoulder Test)
It is a measuring instrument that measures the functional limitations of the affected shoulder of patients with shoulder complaints

Secondary Outcome Measures

Full Information

First Posted
January 22, 2019
Last Updated
September 22, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04633083
Brief Title
Range-of-motion Analysis of Reverse Shoulder Arthroplasty
Acronym
ROM
Official Title
Range of Motion Analysis for the Optimization of Reverse Shoulder Arthroplasty Planning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
March 8, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Signs of impingement
Arm Type
Other
Arm Description
a. non- limited ROM i. Endorotation control until lumbosacral level ii. Scapular plane abduction above 150° b. limited ROM i. Endorotation control lower then lumbosacral level ii. Scapular plane abduction under 150° Intervention: clinical data, imaging data, movement analysis, EOS measurements, ROM simulation
Arm Title
No Signs of impingement
Arm Type
Other
Arm Description
a. non- limited ROM i. Endorotation control until lumbar level ii. Scapular plane abduction above 150° b. limited ROM i. Endorotation control lower then lumbar level ii. Scapular plane abduction under 150° Intervention: clinical data, imaging data, movement analysis, EOS measurements, ROM simulation
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demographic data (Sex)
Description
Sex
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Demographic data (Birth year)
Description
Birth year
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Demographic data (Body Mass Index)
Description
Body Mass Index in kg/m2 (physiological parameter)
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Demographic data (Range of motion)
Description
Range of motion in degrees (physiological parameter)
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Imaging data
Description
Pre- and post-surgery CT scan
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Movement analysis
Description
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
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Stereo Radiographic EOS Measurements
Description
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)
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
ROM simulation
Description
Simulate the ROM of the 2 patient groups based on the available CT scan data
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
EQ-5D-3L questionnaire
Description
It is a questionnaire to measure health-related quality of life
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Tampa scale for kinesiophobia (fear of movement)
Description
It is a questionnaire that gives an impression of the degree of pain-related fear in patients with low back pain (LBP) or fibromyalgia.
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
Constant Score
Description
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
ADLER (Activities of Daily Living [ADL] which require active External Rotation [ER])
Description
It measures the severity of the potential handicap
Time Frame
1-time assessment at a time of 1 or more years postoperatively
Title
SST (Simple Shoulder Test)
Description
It is a measuring instrument that measures the functional limitations of the affected shoulder of patients with shoulder complaints
Time Frame
1-time assessment at a time of 1 or more years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Verhaegen, MD
Organizational Affiliation
Medical Doctor, Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven, campus Pellenberg
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Range-of-motion Analysis of Reverse Shoulder Arthroplasty

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