Rotator Cuff RepairPOCICONCT06257979
Unexpected Positive Cultures in Rotator Cuff Revision Surgery
A study testing This study is with minimal risk and minimal constraints due to the addition of questionnaires in people with Rotator Cuff Repair, run by Elsan at 8 sites in France.
Trial summary
In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Repair
- What is being tested?
- This study is with minimal risk and minimal constraints due to the addition of questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesFrance
- Study dates
- 27 Feb 2024to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged 18 or over
- Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay <2 years)
- Patient requiring arthroscopy
- Patient having had realized a MRI of the shoulder in the 6 previous months
- Affiliate participant or beneficiary of a social security scheme
- Participant having been informed and not having objected to the use of their data
Who cannot join
- Patient with at least one clinical sign of infection (fever, redness)
- Patient with a new distant rupture on a healed cuff (> 3 years)
- Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery
- Patient having received antibiotic treatment in the 2 weeks preceding inclusion
- Participant in another research
- Participant in a period of exclusion from another research still in progress at the time of inclusion
Show all 9Show fewer
- Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman
- Participant hospitalized without consent
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Hôpital privé La Châtaigneraie ELSAN
Beaumont, 63110
METAIS Pierre, MD, pierremetais@mac.com
- Not yet recruiting
Hôpital privé Saint-Martin
Caen, 14050
Franck DORDAIN, MD, fdordain@gmail.com
- Not yet recruiting
Clinique Louis Pasteur
Essey-lès-Nancy, 54270
Adrien JACQUOT, MD
- Not yet recruiting
Santy-Lyon-Ramsay
Lyon, 69008
Philippe COLLOTTE, MD, docteurcollotte@gmail.com
- Not yet recruiting
Clinique d'occitanie ELSAN
Muret, 31600
Benjamin ADAMCZEWSKI, MD, benjamin.adamczewski@gmail.com
- Not yet recruiting
ICR-Kantys
Nice, 06000
Mikaël CHELLI, MD, dr.chelli@icr-nice.com
- Not yet recruiting
Santé Atlantique ELSAN
Saint-Herblain, 44800
Yves BOUJU, MD, yves.bouju@gmail.com
- Recruiting
Clinique de l'Orangerie
Strasbourg
Maxime Antony, MD, 0033 6 50 35 21 12, antoni@epaule-coude-orangerie.fr
About this study
Official title: Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.
A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.
Read the detailed description
Rotator cuff injuries are a common pathology with a 30% prevalence in the general population. If rotator cuff repair fails, patients often experience persistent pain, and bacteria can be detected during the revision period in approximately 30% of cases, even in the absence of septic symptoms. This type of infection, referred to as low-level infection, occurs in around 5% of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention.
Bacteriological samples are routinely collected during revisions, especially for prostheses. The appropriate course of action in cases where these samples test positive, yet there are no signs of infection, remains to be clarified. Notably, administering antibiotics in response to unexpected positive cultures (UPC) during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates.
In the context of rotator cuff re-interventions, the impact of UPC has not been well-documented. The management of UPC, particularly regarding antibiotic therapy, has not been thoroughly studied and is not currently recommended. Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions.
- Conditions
- Rotator Cuff Repair
- Being tested
- This study is with minimal risk and minimal constraints due to the addition of questionnaires
- Keywords
- Unexpected Positive Cultures (UPC), Revision cuff repair surgery (RCR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is with minimal risk and minimal constraints due to the addition of questionnairesOther
Also called Microbiological analysis of samples collected from operated patients: in the presence of UPC, it does not influence the postoperative course, No antibiotics are prescribed during the first month after the operation.
In this study, the specific procedures compared to routine care are :
- Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research.
- The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis.
- Antibiotic treatment cannot be prescribed immediately after the surgery and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Other | Operated patients with positive results for their pre-operative microbiological samples. Receives: Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires |
| Control group | Other | Operated patients with negative results for their pre-operative microbiological samples. Receives: Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results.
Compare the functional recovery (Yes/No), at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results using the Constant Score.
Measured: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff
Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.
Measured: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff
Compare the 2 groups on the occurrence of post-operative complications (Yes/No), after iterative repair of non-healing of the rotator cuff and list them
Measured: up to one year after the re-intervention
Compare the 2 groups on the patient's other functional scores
Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries
Measured: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Describe the pathogenic germs found in the positive cultures
List of pathogenic germs found in the positive samples
Measured: at Month 1 after the re-intervention
Secondary outcomes (5)
Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing
The quality of the repair was assessed using an MRI and the Sugaya classification (French version):
Type 1: Normal thickness and echostructure of the rotator cuff. Type 2: Normal thickness and heterogeneous echostructure. Type 3: Thinning without discontinuity. Type 4: Moderate discontinuity. Type 5: Frank discontinuity.
Measured: at one year after the re-intervention
Occurrence of complications during the first post-operative year
List of of complications during the first post-operative year
Measured: up to one year after the re-intervention
Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)
ASES score can be viewed as a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.
Measured: at one year after the re-intervention
Functional scores at one year: Subjective Shoulder Value (SSV)
SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
Measured: at one year after the re-intervention
Pathogenic bacteria detected in the group of patients with positive results
List of pathogenic bacteria detected in the group of patients with positive results
Measured: at Month 1 after the re-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start27 Feb 2024
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study procedure involves a re-intervention of the rotator cuff, which is conducted for the patients in accordance with standard practice. The patient undergoes local and/or general anesthesia, along with intravenous or oral antibiotic prophylaxis. During the intervention, the surgeon collects the sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product) used during the re-intervention. These elements usually discarded, are collected for the bacteriological analysis. Antibiotic treatment cannot be prescribed immediately and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime ANTONI, MD, Study director, Clinique de l'Orangerie-Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257979
- Sponsor's protocol ID
- 2023-A02042-43
- Acronym
- POCICO
- Status last verified
- Jun 2024
- First submitted
- 5 Jan 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Luo M, Pan J, Liang G, Feng W, Zeng L, Yang W, Liu J. Risk factors affecting rotator cuff retear after arthroscopic repair: a meta-analysis and systematic review. J Shoulder Elbow Surg. 2021 Nov;30(11):2660-2670. doi: 10.1016/j.jse.2021.05.010. Epub 2021 Jun 2.
PubMed 34089878Azar M, Van der Meijden O, Pireau N, Chelli M, Gonzalez JF, Boileau P. Arthroscopic revision cuff repair: do tendons have a second chance to heal? J Shoulder Elbow Surg. 2022 Dec;31(12):2521-2531. doi: 10.1016/j.jse.2022.04.024. Epub 2022 Jun 6.
PubMed 35671929Bonnevialle N, Dauzeres F, Toulemonde J, Elia F, Laffosse JM, Mansat P. Periprosthetic shoulder infection: an overview. EFORT Open Rev. 2017 Apr 27;2(4):104-109. doi: 10.1302/2058-5241.2.160023. eCollection 2017 Apr.
PubMed 28507783Neufeld ME, Lanting BA, Shehata M, Naudie DDR, McCalden RW, Teeter MG, Vasarhelyi EM. The Prevalence and Outcomes of Unexpected Positive Intraoperative Cultures in Presumed Aseptic Revision Knee Arthroplasty. J Arthroplasty. 2022 Nov;37(11):2262-2271. doi: 10.1016/j.arth.2022.05.036. Epub 2022 May 19.
PubMed 35598759Falstie-Jensen T, Lange J, Daugaard H, Sorensen AKB, Ovesen J, Soballe K; ROSA Study Group. Unexpected positive cultures after revision shoulder arthroplasty: does it affect outcome? J Shoulder Elbow Surg. 2021 Jun;30(6):1299-1308. doi: 10.1016/j.jse.2020.12.014. Epub 2021 Feb 3.
PubMed 33548396Hodakowski AJ, Cohn MR, Mehta N, Menendez ME, McCormick JR, Garrigues GE. An evidence-based approach to managing unexpected positive cultures in shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Oct;31(10):2176-2186. doi: 10.1016/j.jse.2022.03.019. Epub 2022 May 2.
PubMed 35513254Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.
PubMed 16325080Angst F, Goldhahn J, Drerup S, Aeschlimann A, Schwyzer HK, Simmen BR. Responsiveness of six outcome assessment instruments in total shoulder arthroplasty. Arthritis Rheum. 2008 Mar 15;59(3):391-8. doi: 10.1002/art.23318.
PubMed 18311752Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
PubMed 18061114
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
- ClinicalTrials.gov ID
- NCT06257979
- Acronym / sponsor ID
- POCICO / 2023-A02042-43
- Conditions
- Rotator Cuff Repair
- Keywords
- Unexpected Positive Cultures (UPC), Revision cuff repair surgery (RCR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.
A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.
Detailed description
Rotator cuff injuries are a common pathology with a 30% prevalence in the general population. If rotator cuff repair fails, patients often experience persistent pain, and bacteria can be detected during the revision period in approximately 30% of cases, even in the absence of septic symptoms. This type of infection, referred to as low-level infection, occurs in around 5% of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention.
Bacteriological samples are routinely collected during revisions, especially for prostheses. The appropriate course of action in cases where these samples test positive, yet there are no signs of infection, remains to be clarified. Notably, administering antibiotics in response to unexpected positive cultures (UPC) during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates.
In the context of rotator cuff re-interventions, the impact of UPC has not been well-documented. The management of UPC, particularly regarding antibiotic therapy, has not been thoroughly studied and is not currently recommended. Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study procedure involves a re-intervention of the rotator cuff, which is conducted for the patients in accordance with standard practice. The patient undergoes local and/or general anesthesia, along with intravenous or oral antibiotic prophylaxis. During the intervention, the surgeon collects the sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product) used during the re-intervention. These elements usually discarded, are collected for the bacteriological analysis. Antibiotic treatment cannot be prescribed immediately and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Other | Other: This study is with minimal risk and minimal constraints due to the addition of questionnairesOperated patients with positive results for their pre-operative microbiological samples. |
| Control group | Other | Other: This study is with minimal risk and minimal constraints due to the addition of questionnairesOperated patients with negative results for their pre-operative microbiological samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient, male or female, aged 18 or over
- Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay <2 years)
- Patient requiring arthroscopy
- Patient having had realized a MRI of the shoulder in the 6 previous months
- Affiliate participant or beneficiary of a social security scheme
Key exclusion criteria (9 listed)
- Patient with at least one clinical sign of infection (fever, redness)
- Patient with a new distant rupture on a healed cuff (> 3 years)
- Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery
- Patient having received antibiotic treatment in the 2 weeks preceding inclusion
- Participant in another research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is with minimal risk and minimal constraints due to the addition of questionnairesAlso: Microbiological analysis of samples collected from operated patients: in the presence of UPC, it does not influence the postoperative course, No antibiotics are prescribed during the first month after the operation.In this study, the specific procedures compared to routine care are : * Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research. * The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis. * Antibiotic treatment cannot be prescribed immediately after the surgery and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study. | Other | Control group, Experimental group |
Primary outcome
Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results.
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the functional recovery (Yes/No), at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results using the Constant Score.
Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.
Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff
Time frame: up to one year after the re-intervention
Compare the 2 groups on the occurrence of post-operative complications (Yes/No), after iterative repair of non-healing of the rotator cuff and list them
Compare the 2 groups on the patient's other functional scores
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries
Describe the pathogenic germs found in the positive cultures
Time frame: at Month 1 after the re-intervention
List of pathogenic germs found in the positive samples
5 secondary outcomes
Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing
Time frame: at one year after the re-intervention
Occurrence of complications during the first post-operative year
Time frame: up to one year after the re-intervention
Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)
Time frame: at one year after the re-intervention
Functional scores at one year: Subjective Shoulder Value (SSV)
Time frame: at one year after the re-intervention
Pathogenic bacteria detected in the group of patients with positive results
Time frame: at Month 1 after the re-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 34089878Zhao J, Luo M, Pan J, Liang G, Feng W, Zeng L, Yang W, Liu J. Risk factors affecting rotator cuff retear after arthroscopic repair: a meta-analysis and systematic review. J Shoulder Elbow Surg. 2021 Nov;30(11):2660-2670. doi: 10.1016/j.jse.2021.05.010. Epub 2021 Jun 2.
- Background: PubMed 35671929Azar M, Van der Meijden O, Pireau N, Chelli M, Gonzalez JF, Boileau P. Arthroscopic revision cuff repair: do tendons have a second chance to heal? J Shoulder Elbow Surg. 2022 Dec;31(12):2521-2531. doi: 10.1016/j.jse.2022.04.024. Epub 2022 Jun 6.
- Background: PubMed 28507783Bonnevialle N, Dauzeres F, Toulemonde J, Elia F, Laffosse JM, Mansat P. Periprosthetic shoulder infection: an overview. EFORT Open Rev. 2017 Apr 27;2(4):104-109. doi: 10.1302/2058-5241.2.160023. eCollection 2017 Apr.
- Background: PubMed 35598759Neufeld ME, Lanting BA, Shehata M, Naudie DDR, McCalden RW, Teeter MG, Vasarhelyi EM. The Prevalence and Outcomes of Unexpected Positive Intraoperative Cultures in Presumed Aseptic Revision Knee Arthroplasty. J Arthroplasty. 2022 Nov;37(11):2262-2271. doi: 10.1016/j.arth.2022.05.036. Epub 2022 May 19.
- Background: PubMed 33548396Falstie-Jensen T, Lange J, Daugaard H, Sorensen AKB, Ovesen J, Soballe K; ROSA Study Group. Unexpected positive cultures after revision shoulder arthroplasty: does it affect outcome? J Shoulder Elbow Surg. 2021 Jun;30(6):1299-1308. doi: 10.1016/j.jse.2020.12.014. Epub 2021 Feb 3.
- Background: PubMed 35513254Hodakowski AJ, Cohn MR, Mehta N, Menendez ME, McCormick JR, Garrigues GE. An evidence-based approach to managing unexpected positive cultures in shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Oct;31(10):2176-2186. doi: 10.1016/j.jse.2022.03.019. Epub 2022 May 2.
- Background: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
- Background: PubMed 16325080Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.
- Background: PubMed 18311752Angst F, Goldhahn J, Drerup S, Aeschlimann A, Schwyzer HK, Simmen BR. Responsiveness of six outcome assessment instruments in total shoulder arthroplasty. Arthritis Rheum. 2008 Mar 15;59(3):391-8. doi: 10.1002/art.23318.
- Background: PubMed 18061114Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxime ANTONI, MD study director
Clinique de l'Orangerie-Strasbourg
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This study is with minimal risk and minimal constraints due to the addition of questionnaires in people with Rotator Cuff Repair, run by Elsan at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albatoul ZAKARIA, PhD (0033 6 49 77 17 52, zakaria@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results. (time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257979, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.