Shoulder ImpingementROMNCT04633083
Range-of-motion Analysis of Reverse Shoulder Arthroplasty
A study testing Data collection in people with Shoulder Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2019to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Only RSA patients with a functional RSA will be included, so patients with postoperative stiffness, pain, instability or pseudoparalysis will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Range of Motion Analysis for the Optimization of Reverse Shoulder Arthroplasty Planning
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.
Read the 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.
- Conditions
- Shoulder Impingement
- Being tested
- Data collection
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Signs of impingement | Other | 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 Receives: Other: Data collection |
| No Signs of impingement | Other | 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 Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data (Sex)
Sex
Measured: 1-time assessment at a time of 1 or more years postoperatively
Demographic data (Birth year)
Birth year
Measured: 1-time assessment at a time of 1 or more years postoperatively
Demographic data (Body Mass Index)
Body Mass Index in kg/m2 (physiological parameter)
Measured: 1-time assessment at a time of 1 or more years postoperatively
Demographic data (Range of motion)
Range of motion in degrees (physiological parameter)
Measured: 1-time assessment at a time of 1 or more years postoperatively
Imaging data
Pre- and post-surgery CT scan
Measured: 1-time assessment at a time of 1 or more years postoperatively
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
Measured: 1-time assessment at a time of 1 or more years postoperatively
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)
Measured: 1-time assessment at a time of 1 or more years postoperatively
ROM simulation
Simulate the ROM of the 2 patient groups based on the available CT scan data
Measured: 1-time assessment at a time of 1 or more years postoperatively
EQ-5D-3L questionnaire
It is a questionnaire to measure health-related quality of life
Measured: 1-time assessment at a time of 1 or more years postoperatively
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.
Measured: 1-time assessment at a time of 1 or more years postoperatively
Constant Score
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient
Measured: 1-time assessment at a time of 1 or more years postoperatively
ADLER (Activities of Daily Living [ADL] which require active External Rotation [ER])
It measures the severity of the potential handicap
Measured: 1-time assessment at a time of 1 or more years postoperatively
SST (Simple Shoulder Test)
It is a measuring instrument that measures the functional limitations of the affected shoulder of patients with shoulder complaints
Measured: 1-time assessment at a time of 1 or more years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start20 Mar 2019
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Verhaegen, MD, Principal investigator, Medical Doctor, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633083
- Sponsor's protocol ID
- S62153
- Acronym
- ROM
- Status last verified
- Sep 2023
- First submitted
- 22 Jan 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Range of Motion Analysis for the Optimization of Reverse Shoulder Arthroplasty Planning
- ClinicalTrials.gov ID
- NCT04633083
- Acronym / sponsor ID
- ROM / S62153
- Conditions
- Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Signs of impingement | Other | Other: Data collectiona. 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 |
| No Signs of impingement | Other | Other: Data collectiona. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Only RSA patients with a functional RSA will be included, so patients with postoperative stiffness, pain, instability or pseudoparalysis will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionClinical 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. | Other | No Signs of impingement, Signs of impingement |
Primary outcome
Demographic data (Sex)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Sex
Demographic data (Birth year)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Birth year
Demographic data (Body Mass Index)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Body Mass Index in kg/m2 (physiological parameter)
Demographic data (Range of motion)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Range of motion in degrees (physiological parameter)
Imaging data
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Pre- and post-surgery CT scan
Movement analysis
Time frame: 1-time assessment at a time of 1 or more years postoperatively
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
Time frame: 1-time assessment at a time of 1 or more years postoperatively
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
Time frame: 1-time assessment at a time of 1 or more years postoperatively
Simulate the ROM of the 2 patient groups based on the available CT scan data
EQ-5D-3L questionnaire
Time frame: 1-time assessment at a time of 1 or more years postoperatively
It is a questionnaire to measure health-related quality of life
Tampa scale for kinesiophobia (fear of movement)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
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
Time frame: 1-time assessment at a time of 1 or more years postoperatively
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])
Time frame: 1-time assessment at a time of 1 or more years postoperatively
It measures the severity of the potential handicap
SST (Simple Shoulder Test)
Time frame: 1-time assessment at a time of 1 or more years postoperatively
It is a measuring instrument that measures the functional limitations of the affected shoulder of patients with shoulder complaints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Verhaegen, MD principal investigator
Medical Doctor, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection in people with Shoulder Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (Sex) (time frame: 1-time assessment at a time of 1 or more years postoperatively). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.