ArthroPlanner: A Surgical Planning Solution for Acromioplasty

NCT02725346 | Unknown DMC

• 1 other identifier: GE 15-151
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shoulder Impingement Syndrome; Subacromial Impingement Syndrome; Tendon Injuries

Keywords

Surgical Planning Solution; Acromioplasty; Shoulder Surgery; Critical Shoulder Angle

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Percentage of gain of range of motion between groups of postoperative range of motion

  6 month

• Constant score

  6 months

• American Shoulder and Elbow Surgeons score

  6 months

• Simple shoulder value

  6 months

• Single Assessment Numeric Evaluation score

  6 months

Study Arms (2)

Computer-assisted planning

EXPERIMENTAL

Acromioplasty with planification

Procedure: Acromioplasty with planning

No planning

ACTIVE COMPARATOR

Acromioplasty without planification

Procedure: Acromioplasty without planning

Interventions

Acromioplasty with planning PROCEDURE

Computer-assisted planning

Acromioplasty without planning PROCEDURE

No planning

Eligibility Criteria

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

You may qualify if:

• Arthroscopic supraspinatus repair

You may not qualify if:

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

Sponsors & Collaborators

• Adrien Schwitzguebel: lead

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 5054450 BACKGROUND

• 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.

  PMID: 16595470 BACKGROUND

• 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.

  PMID: 15844264 BACKGROUND

• 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.

  PMID: 23814246 BACKGROUND

• 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.

  PMID: 26350880 BACKGROUND

• 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.

  PMID: 25503926 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Tendon Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 1, 2016
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

CH (1)