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Shoulder Impingement SyndromeNCT02725346

ArthroPlanner: A Surgical Planning Solution for Acromioplasty

A study testing Acromioplasty with planning and Acromioplasty without planning in people with Shoulder Impingement Syndrome and Subacromial Impingement Syndrome, run by Adrien Schwitzguebel at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A computer-assisted solution for acromioplasty is presented. The software allows surgeons to better plan the surgical procedure by visualizing dynamic simulation of the patient's shoulder joint during everyday activities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acromioplasty with planning and Acromioplasty without planning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteSwitzerland
Study dates
Jul 2015to Dec 2016
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

  • Arthroscopic supraspinatus repair

Who cannot join

  • Incomplete documentation
  • Follow-up of less than six months
  • Previous shoulder surgery
  • Contraindications for computed tomography

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • La Tour Hospital

    Meyrin, Canton of Geneva, 1217

Other trials in Switzerland

About this study

A computer-assisted solution for acromioplasty is presented. The software allows surgeons to better plan the surgical procedure by visualizing dynamic simulation of the patient's shoulder joint during everyday activities. Impingements are dynamically detected and the exact location and amount of bone to be resected is precisely computed. As a result, the success of the acromioplasty does not only rely on the surgeon's experience or previous recommendations, but on quantitative data. Although the clinical validation of this 3D planning support is currently under evaluation, it may allow to recover more effectively postoperative joint mobility, to get a better relationship with pain and a better healing rate of the rotator cuff tendons.

Read the detailed description

Introduction Subacromial impingement of the rotator cuff between the anterior [1] or lateral acromion [2] and the superior humeral head is a common disorder. This condition arises when the subacromial space height is too narrow during active elevation or scaption of the arm above shoulder level due to an abnormal hooked shape or large lateral extension of the acromion.

In severe cases of impingement syndrome, an arthroscopic acromioplasty surgery is usually performed to resect the different area of the acromion causing damage to the subacromial structures. The exact location and the amount of bone to be resected is generally left to the unique appreciation of the orthopedic surgeon during surgery. To improve the precision of this resection, surgeons could greatly benefit from a surgical planning solution that aims at providing precise information about the surgical procedure. Moreover, since subacromial impingements are the result of a dynamic mechanism, an effective planning solution should analyze both the morphological joint's structures and its dynamic behavior during shoulder movements to fully apprehend the patient joint's condition.

Computer-assisted planning solution "ArthroPlanner" for acromioplasty is nowadays available. The solution allows to perform standard morphological bony measurements, as well as 3D simulations of the patient's joint during everyday shoulder activities. The software computes the precise bone resection (location and amount) based on detected subacromial impingements during motion.

The goal of this study was thus to compare clinical and radiological results of superior rotator cuff repair with or without computer-assisted planning. The hypothesis was that preoperative planning of acromioplasty would allowed more accurate bone resection, would decrease postoperative impingements and consequently improved postoperative range of motion and tendon healing.

Methods

We reconstruct the bones of the patient's shoulder joint (scapula and humerus from the humeral head to the mid-shaft) from a CT image using Mimics software (Materialise NV, Leuven, Belgium). The bones are then imported into ArthroPlanner software and the following steps are performed:

First, generic bone models are produced using a template fitting approach that deforms a bone template with an optimized topology (one for the scapula and one for humerus) to the reconstructed bone. This allows us in the next steps to exploit anatomical correspondences and to automatize landmarks and points selection on the mesh.

Second, biomechanical parameters are computed to permit motion description of the glenohumeral joint. The glenohumeral joint center is automatically calculated by a sphere fitting technique [3] that fits a sphere to the humeral head using the points of the proximal humerus model. Bone coordinate systems are established for the scapula and humerus. based on the definitions suggested by the International Society of Biomechanics [4] using anatomical landmarks defined on the bone models. Missing landmarks such as the lateral and medial epicondyles are identified on the CT image.

Third, morphological measurements are performed to analyze individual shoulder anatomy. The Critical Shoulder Angle [5] and the β angle [6] are calculated, as they are criteria associated with rotator cuff tears. The angles are computed in 3D based on bony landmarks and can be, if necessary, interactively adjusted by the user by manipulating 3D handles in the viewer.

Fourth, motion is applied at each time step to the humerus model with real-time evaluation of impingement. The minimum humero-acromial distance that is typically used for the evaluation of subacromial impingement is measured [7]. This distance is calculated in millimeters based on the simulated bones models positions. A color scale is also used to map the variations of distance on the scapula surface (red color = minimum distance, other colors = areas of increased distance). Given the thickness of the potential impinged tissues, subacromial impingement is considered when the computed humero-acromial distance is < 6 mm, as suggested in the literature [7]. To test a wide variability of realistic movements, a motion database of daily activities (e.g., cross arm, comb hair) is used in addition to standard kinematic sequences (e.g., elevation, scaption).

Finally, the acromial resection plan is defined based on the 3D simulation results. A color map is used to represent areas where impingements occurred between the acromion and humerus (Fig. 1D). The red color denotes the area with the smallest humero-acromial distance computed over the different motion simulations.

The results at each step of the planning procedure are carefully validated by the user before continuing to the next ones. At the end of the planning, a PDF report is generated that contains patient's information and the measurements performed. The bones and the simulation data are also exported to be used in a simple 3D viewer (Fig. 2) dedicated to the surgeon. With this viewer, the surgeon is able to play all simulations, observe impingements dynamically and review the resection plan.

Being tested
Acromioplasty with planning, Acromioplasty without planning
Keywords
Surgical Planning Solution, Acromioplasty, Shoulder Surgery, Critical Shoulder Angle
Medical subject headings
Shoulder Impingement Syndrome, Tendon Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acromioplasty with planningProcedure or surgery

  • Acromioplasty without planningProcedure or surgery

Study groups in NCT02725346
Study groupRoleWhat they receive
Computer-assisted planningExperimentalAcromioplasty with planification
Receives: Procedure: Acromioplasty with planning
No planningActive comparatorAcromioplasty without planification
Receives: Procedure: Acromioplasty without planning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume in mm3 of bone removal in four zones determine between pre- and postoperative computed tomography

    Accuracy of acromioplasty in relation to preoperative planning (zone 1 anterior, zone 2 lateral, zone 3 medial, zone 4 central).

    Measured: 6 months

  2. Tendon healing determine with ultrasound with Sugaya criteria

    ultrasound realized by a blinded radiologist. This outcome will be considered as primary only if the first primary outcome is reached. Otherwise it will considered as a secondary outcome.

    Measured: 6 month

Secondary outcomes (5)
  1. Percentage of gain of range of motion between groups of postoperative range of motion

    Evaluated by a independent and blind observer with dedicated software

    Measured: 6 month

  2. Constant score

    Measured: 6 months

  3. American Shoulder and Elbow Surgeons score

    Measured: 6 months

  4. Simple shoulder value

    Measured: 6 months

  5. Single Assessment Numeric Evaluation score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionFeb 2016
  4. Study completionDec 2016 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725346
Sponsor's protocol ID
GE 15-151
Status last verified
May 2016
First submitted
11 Mar 2016
Last updated
19 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.

    PubMed 5054450
  • Nyffeler RW, Werner CM, Sukthankar A, Schmid MR, Gerber C. Association of a large lateral extension of the acromion with rotator cuff tears. J Bone Joint Surg Am. 2006 Apr;88(4):800-5. doi: 10.2106/JBJS.D.03042.

    PubMed 16595470
  • Wu G, van der Helm FC, Veeger HE, Makhsous M, Van Roy P, Anglin C, Nagels J, Karduna AR, McQuade K, Wang X, Werner FW, Buchholz B; International Society of Biomechanics. ISB recommendation on definitions of joint coordinate systems of various joints for the reporting of human joint motion--Part II: shoulder, elbow, wrist and hand. J Biomech. 2005 May;38(5):981-992. doi: 10.1016/j.jbiomech.2004.05.042.

    PubMed 15844264
  • Moor BK, Bouaicha S, Rothenfluh DA, Sukthankar A, Gerber C. Is there an association between the individual anatomy of the scapula and the development of rotator cuff tears or osteoarthritis of the glenohumeral joint?: A radiological study of the critical shoulder angle. Bone Joint J. 2013 Jul;95-B(7):935-41. doi: 10.1302/0301-620X.95B7.31028.

    PubMed 23814246
  • Daggett M, Werner B, Collin P, Gauci MO, Chaoui J, Walch G. Correlation between glenoid inclination and critical shoulder angle: a radiographic and computed tomography study. J Shoulder Elbow Surg. 2015 Dec;24(12):1948-53. doi: 10.1016/j.jse.2015.07.013. Epub 2015 Sep 6.

    PubMed 26350880
  • Charbonnier C, Chague S, Kolo FC, Ladermann A. Shoulder motion during tennis serve: dynamic and radiological evaluation based on motion capture and magnetic resonance imaging. Int J Comput Assist Radiol Surg. 2015 Aug;10(8):1289-97. doi: 10.1007/s11548-014-1135-4. Epub 2014 Dec 14.

    PubMed 25503926

Questions about this trial

What is this clinical trial studying?

A study testing Acromioplasty with planning and Acromioplasty without planning in people with Shoulder Impingement Syndrome and Subacromial Impingement Syndrome, run by Adrien Schwitzguebel at 1 site in Switzerland.

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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 May 2016. 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 Switzerland. 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?

Results are not available in the source record.

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?

Volume in mm3 of bone removal in four zones determine between pre- and postoperative computed tomography (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725346, which also lists 6 linked publications.

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 19 May 2016.

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