Range-of-motion Analysis of Reverse Shoulder Arthroplasty

NCT04633083 | Completed

• 1 other identifier: S62153
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement

Outcome Measures

Primary Outcomes (13)

• Demographic data (Sex)

  Sex

  1-time assessment at a time of 1 or more years postoperatively

• Demographic data (Birth year)

  Birth year

  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)

  1-time assessment at a time of 1 or more years postoperatively

• Demographic data (Range of motion)

  Range of motion in degrees (physiological parameter)

  1-time assessment at a time of 1 or more years postoperatively

• Imaging data

  Pre- and post-surgery CT scan

  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

  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)

  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

  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

  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.

  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

  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

  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

  1-time assessment at a time of 1 or more years postoperatively

Study Arms (2)

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

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

Other: Data collection

Interventions

Data collection OTHER

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.

No Signs of impingement; Signs of impingement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven, campus Pellenberg

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Filip Verhaegen, MD

  Medical Doctor, Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: November 18, 2020
• Study Start: March 20, 2019
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)