Shoulder Impingement Syndrome Clinical Trial
Official title:
ArthroPlanner: A Surgical Planning Solution for Acromioplasty
Verified date | May 2016 |
Source | La Tour Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 67 |
Est. completion date | December 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Arthroscopic supraspinatus repair Exclusion Criteria: - Incomplete documentation - Follow-up of less than six months - Previous shoulder surgery - Contraindications for computed tomography |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | La Tour Hospital | Meyrin | Geneva |
Lead Sponsor | Collaborator |
---|---|
Adrien Schwitzguebel |
Switzerland,
Charbonnier C, Chagué S, Kolo FC, Lädermann 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 6 months | No |
Primary | 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. | 6 month | No |
Secondary | Percentage of gain of range of motion between groups of postoperative range of motion | Evaluated by a independent and blind observer with dedicated software | 6 month | No |
Secondary | Constant score | 6 months | No | |
Secondary | American Shoulder and Elbow Surgeons score | 6 months | No | |
Secondary | Simple shoulder value | 6 months | No | |
Secondary | Single Assessment Numeric Evaluation score | 6 months | No |
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