Clinical Study on Mesenchymal Stem Cells Used in the Reconstruction Surgery of the Supraspinatus Muscle Lesions
Mesenchymal Stem Cells in the Reconstruction Surgery of the Supraspinatus Muscle Lesions
1 other identifier
interventional
50
1 country
1
Brief Summary
The prospective randomized clinical study investigating the effect of mesenchymal stem cells on tendon healing. The objective of the study is to demonstrate the effect of concentrated bone marrow stem cells ( MSCs ) to the healing of sutured tendon of the supraspinatus muscle in comparison to the same procedure performed without MSCs. We have postulated the hypothesis that MSCs enhance the healing of the sutured supraspinatus tendon to its humeral footprint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 7, 2017
September 1, 2017
3 years
February 20, 2017
September 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The supraspinatus tendon re-rupture rate
presence of the supraspinatus tendon rupture on magnetic resonance imaging evaluated 2 years after the surgery, incidence of rerupture compared between group I- with the use of mesenchymal stem cells and group II- without the use of mesenchymal stem cells
2 years postoperatively
Secondary Outcomes (3)
visual analogue scale
1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively
ASES score- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively
Constant score
1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively
Study Arms (2)
mesenchymal stem cells
EXPERIMENTALmesenchymal stem cells concentrate into the supraspinatus footprint during the surgery
without mesenchymal stem cells
PLACEBO COMPARATORrotator cuff surgery without mesenchymal stem cells
Interventions
mesenchymal stem cells concentrate into the supraspinatus footprint during the surgery
rotator cuff surgery without mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- men and women aged 18-60 years
- chronic supraspinatus tendon tear greater than 50% of its width
- no history of trauma to the examined shoulder girdle
- confirmation by the clinical examination and preoperative imaging examination ( MRI arthrography )
- signed informed consent
- minimum preoperative haemoglobin concentration in men 13.8 g / dl, in women 12.1 g / dl
You may not qualify if:
- previous surgical treatment of the rotator cuff
- cuff tear arthropathy grade 3-5 according to Hamada
- fatty degeneration of the cuff muscle ( Goutallier 3 and 4 )
- atrophy of the supraspinatus muscle according to the Thomazeau classification grade II and III
- retraction of the supraspinatus muscle tendon Patte III
- pregnancy
- active infection at the surgical site or elsewhere in the body
- osteomyelitis
- sepsis
- history of diabetes
- steroids use
- chemotherapy
- use of NSAIDs
- radiation
- hepatitis
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Znojmolead
Study Sites (1)
Petr Šmíd
Znojmo, Czech Republic, 66902, Czechia
Related Publications (5)
Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994 Jul;(304):78-83.
PMID: 8020238RESULTThomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.
PMID: 9372778RESULTPatte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
PMID: 2323151RESULTRichards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
PMID: 22958838RESULTConstant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PMID: 3791738RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Šmíd, Dr.
General Hospital Znojmo, Czech Republic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal investigator, Doctor
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 3, 2017
Study Start
January 1, 2012
Primary Completion
December 31, 2014
Study Completion
December 31, 2021
Last Updated
September 7, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share