NCT04913935|CompletedDMC
Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA
Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA
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Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA
Sponsor study identifier
observational
24
1 country
1
Study Start
September 5, 2019
Actual (reported)Primary Completion
December 28, 2019
Actual (reported)Study Completion
January 15, 2020
Actual (reported)In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2019
Actual (reported)September 5, 2019
Actual (reported)December 28, 2019
Actual (reported)January 15, 2020
Actual (reported)June 4, 2021
Actual (reported)Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
USG procedures will performed on patients with TMC OA and healthy volunteers. Cross-sectional area measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
through study completion, an average of 1 year
Ultrasound-based muscle thickness of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
women who were diagnosed with TMC OA
healty volunteer women
postero-anterior radiography
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years and who had the intellectual capacity to give informed consent for the treatment were included in the study.
Hacettepe University
Altindağ, Ankara, 06100, Turkey (Türkiye)
Wolf JM, Oren TW, Ferguson B, Williams A, Petersen B. The carpometacarpal stress view radiograph in the evaluation of trapeziometacarpal joint laxity. J Hand Surg Am. 2009 Oct;34(8):1402-6. doi: 10.1016/j.jhsa.2009.06.030. Epub 2009 Sep 10.
Mohseny B, Nijhuis TH, Hundepool CA, Janssen WG, Selles RW, Coert JH. Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strength. Arch Phys Med Rehabil. 2015 May;96(5):845-53. doi: 10.1016/j.apmr.2014.11.014. Epub 2014 Dec 4.
ÇİĞDEM AYHAN, ASS. PROF.
Hacettepe University
24 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2019
First Posted
June 4, 2021
Study Start
September 5, 2019
Actual (reported)USG procedures will performed on patients with TMC OA and healthy volunteers.Thickness measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
through study completion, an average of 1 year
The radial subluxation rate of the first metacarpal.
through study completion, an average of 1 year
Evaluation of functional status of hand
through study completion, an average of 1 year
Grip strength measurement
through study completion, an average of 1 year
Evaluation of functional status of hand
through study completion, an average of 1 year
Pain Assessment
through study completion, an average of 1 year
Contact the study team to confirm eligibility.
Grechenig W, Peicha G, Weiglein A, Tesch P, Lawrence K, Mayr J, Preidler KW. Sonographic evaluation of the thenar compartment musculature. J Ultrasound Med. 2000 Nov;19(11):733-41. doi: 10.7863/jum.2000.19.11.733.
Primary Completion
December 28, 2019
Actual (reported)Study Completion
January 15, 2020
Actual (reported)Last Updated
June 4, 2021
Record last verified: 2021-06
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