- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725346
ArthroPlanner: A Surgical Planning Solution for Acromioplasty
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Geneva
-
Meyrin, Geneva, Switzerland, 1217
- La Tour Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Arthroscopic supraspinatus repair
Exclusion Criteria:
- Incomplete documentation
- Follow-up of less than six months
- Previous shoulder surgery
- Contraindications for computed tomography
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer-assisted planning
Acromioplasty with planification
|
|
Active Comparator: No planning
Acromioplasty without planification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume in mm3 of bone removal in four zones determine between pre- and postoperative computed tomography
Time Frame: 6 months
|
Accuracy of acromioplasty in relation to preoperative planning (zone 1 anterior, zone 2 lateral, zone 3 medial, zone 4 central).
|
6 months
|
Tendon healing determine with ultrasound with Sugaya criteria
Time Frame: 6 month
|
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.
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of gain of range of motion between groups of postoperative range of motion
Time Frame: 6 month
|
Evaluated by a independent and blind observer with dedicated software
|
6 month
|
Constant score
Time Frame: 6 months
|
6 months
|
|
American Shoulder and Elbow Surgeons score
Time Frame: 6 months
|
6 months
|
|
Simple shoulder value
Time Frame: 6 months
|
6 months
|
|
Single Assessment Numeric Evaluation score
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE 15-151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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