InfiltrationNCT05408065
Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
A study testing Triamcinolone Hexacetonide and hyaluronic acid and Triamcinolone Hexacetonide in people with Infiltration and Shoulder Osteoarthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Infiltration, Shoulder Osteoarthritis
- What is being tested?
- Triamcinolone Hexacetonide and hyaluronic acid and Triamcinolone Hexacetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2022to Dec 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification.
- Patients aged between 20 and 90 years.
- A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study.
- The patient must have a clinical pain threshold of a minimum of 4/10 on the visual analogue scale.
- The patient must have the cognitive ability to read and fill out the questionnaires.
- The patient must be able to read and understand French or English
Who cannot join
- Presence of a transfixing rotator cuff tear assessed on MRI.
- No previous shoulder reconstruction surgery.
- Pregnant woman.
- A patient who has received a cortisone infiltration within 6 months prior to the start of the study.
- A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.
- Diagnosis of avascular necrosis.
Show all 12Show fewer
- Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.)
- Suspicion or presence of active local infectious process.
- Presence or suspicion of neoplasia or local metastasis.
- Severe trauma to the shoulder ( ≤ 3 months)
- Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires.
- Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
Fidaa Al-Shakfa, M.Sc, 5148908000 ext. 26103, f.alshakfa.crchum@gmail.com
Patrice Tétreault, MD FRCSC
About this study
Official title: A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.
For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder.
Method:
- Randomized controlled trial
- Monocentric
- Randomization will be done using sealed envelopes
Read the detailed description
Osteoarthritis is a degenerative joint disease. The progressive erosion of cartilage generates inflammation, pain, and progressive deterioration of joint mobility. Synthetic molecules similar to hyaluronic acid have made it possible to offer patients the option of visco-supplementation by intra-articular injection. It decreases inflammation and pain. CINGAL (Anika Therapeutics, Inc., Bedford, MA), which combines the lubricating action of hyaluronic acid and the anti-inflammatory action of triamcinolone hexacetonide, is one of the available treatments. Several studies have demonstrated the effectiveness of hyaluronic acid in the relief of gonarthrosis. However, the efficacy between an infiltration of hyaluronic acid combined with triamcinolone and a corticosteroid infiltration for glenohumeral osteoarthritis is hardly reviewed in scientific studies.
Primary objective: To compare the analgesic effect of two different infiltrations.
Secondary outcome: To evaluate the patient's functional ability
It is anticipated that a CINGAL infiltration will have a greater beneficial effect than a simple cortisone infiltration in patients with mild to severe shoulder OA.
84 patients with moderate to severe shoulder osteoarthritis will be recruited to receive intra-articular infiltration of CINGAL or cortisone. The infiltration will be randomly assigned. A standard x-ray and magnetic resonance imaging examination will be performed before the infiltration. Demographic data, medical history and 2 questionnaires will be completed prior to infiltration.
Once the evaluation is completed, the patient is randomized and referred to radiology to receive his infiltration under fluoroscopy by a radiologist assigned to the project. Two electronic questionnaires and a medication diary will be sent to the patient at 1, 3 and 6 months post-infiltration.
- Conditions
- Infiltration, Shoulder Osteoarthritis
- Being tested
- Triamcinolone Hexacetonide and hyaluronic acid, Triamcinolone Hexacetonide
- Keywords
- infiltration, Osteoarthritis, hyaluronic acid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Hexacetonide and hyaluronic acidDrug
Also called Cingal
infiltration under fluoroscopy
Triamcinolone HexacetonideDrug
Also called Cortisone
infiltration under fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Cingal | Experimental | A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide Receives: Drug: Triamcinolone Hexacetonide and hyaluronic acid |
| Cortisone | Active comparator | A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25% Receives: Drug: Triamcinolone Hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS score
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
Measured: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration
Secondary outcomes (11)
Change in VAS score
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
Measured: Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration
Change in VAS score
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain
Measured: Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration
Change in QuickDash disability/symptoms score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash disability/symptoms score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change QuickDash disability/symptoms score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Work score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Work score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Work score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Sport/Music score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Sport/Music score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Sport/Music score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Measured: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Nov 2022
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InfiltrationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Tétreault, MD FRCSC, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408065
- Sponsor's protocol ID
- 2023-10659
- Other IDs
- 2023
- Status last verified
- Feb 2024
- First submitted
- 11 May 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brox JI, Lereim P, Merckoll E, Finnanger AM. Radiographic classification of glenohumeral arthrosis. Acta Orthop Scand. 2003 Apr;74(2):186-9. doi: 10.1080/00016470310013932.
PubMed 12807327Hangody L, Szody R, Lukasik P, Zgadzaj W, Lenart E, Dokoupilova E, Bichovsk D, Berta A, Vasarhelyi G, Ficzere A, Hangody G, Stevens G, Szendroi M. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.
PubMed 28535076Noel E, Hardy P, Hagena FW, Laprelle E, Goebel F, Faure C, Favard L, Gaudin P, Christ R, Baudot C, Dietl J, Goupille P. Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study. Joint Bone Spine. 2009 Dec;76(6):670-3. doi: 10.1016/j.jbspin.2009.10.008.
PubMed 19945321He WW, Kuang MJ, Zhao J, Sun L, Lu B, Wang Y, Ma JX, Ma XL. Efficacy and safety of intraarticular hyaluronic acid and corticosteroid for knee osteoarthritis: A meta-analysis. Int J Surg. 2017 Mar;39:95-103. doi: 10.1016/j.ijsu.2017.01.087. Epub 2017 Jan 27.
PubMed 28137554Petrella RJ, Petrella M. A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. J Rheumatol. 2006 May;33(5):951-6.
PubMed 16652426Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.
PubMed 25887932Smith C, Patel R, Vannabouathong C, Sales B, Rabinovich A, McCormack R, Belzile EL, Bhandari M. Combined intra-articular injection of corticosteroid and hyaluronic acid reduces pain compared to hyaluronic acid alone in the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1974-1983. doi: 10.1007/s00167-018-5071-7. Epub 2018 Jul 25.
PubMed 30046992Samilson RL, Prieto V. Dislocation arthropathy of the shoulder. J Bone Joint Surg Am. 1983 Apr;65(4):456-60.
PubMed 6833319Tammachote N, Kanitnate S, Yakumpor T, Panichkul P. Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. J Bone Joint Surg Am. 2016 Jun 1;98(11):885-92. doi: 10.2106/JBJS.15.00544.
PubMed 27252432Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.
PubMed 10512449Zhang B, Thayaparan A, Horner N, Bedi A, Alolabi B, Khan M. Outcomes of hyaluronic acid injections for glenohumeral osteoarthritis: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2019 Mar;28(3):596-606. doi: 10.1016/j.jse.2018.09.011. Epub 2018 Nov 28.
PubMed 30502030
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.
- ClinicalTrials.gov ID
- NCT05408065
- Acronym / sponsor ID
- 2023-10659
- Conditions
- Infiltration, Shoulder Osteoarthritis
- Keywords
- infiltration, Osteoarthritis, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jun 2022 (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.
For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder.
Method:
- Randomized controlled trial
- Monocentric
- Randomization will be done using sealed envelopes
Detailed description
Osteoarthritis is a degenerative joint disease. The progressive erosion of cartilage generates inflammation, pain, and progressive deterioration of joint mobility. Synthetic molecules similar to hyaluronic acid have made it possible to offer patients the option of visco-supplementation by intra-articular injection. It decreases inflammation and pain. CINGAL (Anika Therapeutics, Inc., Bedford, MA), which combines the lubricating action of hyaluronic acid and the anti-inflammatory action of triamcinolone hexacetonide, is one of the available treatments. Several studies have demonstrated the effectiveness of hyaluronic acid in the relief of gonarthrosis. However, the efficacy between an infiltration of hyaluronic acid combined with triamcinolone and a corticosteroid infiltration for glenohumeral osteoarthritis is hardly reviewed in scientific studies.
Primary objective: To compare the analgesic effect of two different infiltrations.
Secondary outcome: To evaluate the patient's functional ability
It is anticipated that a CINGAL infiltration will have a greater beneficial effect than a simple cortisone infiltration in patients with mild to severe shoulder OA.
84 patients with moderate to severe shoulder osteoarthritis will be recruited to receive intra-articular infiltration of CINGAL or cortisone. The infiltration will be randomly assigned. A standard x-ray and magnetic resonance imaging examination will be performed before the infiltration. Demographic data, medical history and 2 questionnaires will be completed prior to infiltration.
Once the evaluation is completed, the patient is randomized and referred to radiology to receive his infiltration under fluoroscopy by a radiologist assigned to the project. Two electronic questionnaires and a medication diary will be sent to the patient at 1, 3 and 6 months post-infiltration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cingal | Experimental | Drug: Triamcinolone Hexacetonide and hyaluronic acidA single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide |
| Cortisone | Active comparator | Drug: Triamcinolone HexacetonideA single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25% |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification.
- Patients aged between 20 and 90 years.
- A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study.
- The patient must have a clinical pain threshold of a minimum of 4/10 on the visual analogue scale.
- The patient must have the cognitive ability to read and fill out the questionnaires.
Key exclusion criteria (12 listed)
- Presence of a transfixing rotator cuff tear assessed on MRI.
- No previous shoulder reconstruction surgery.
- Pregnant woman.
- A patient who has received a cortisone infiltration within 6 months prior to the start of the study.
- A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.
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 |
|---|---|---|
| Triamcinolone Hexacetonide and hyaluronic acidAlso: Cingalinfiltration under fluoroscopy | Drug | Cingal |
| Triamcinolone HexacetonideAlso: Cortisoneinfiltration under fluoroscopy | Drug | Cortisone |
Primary outcome
Change in VAS score
Time frame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
11 secondary outcomes
Change in VAS score
Time frame: Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration
Change in VAS score
Time frame: Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration
Change in QuickDash disability/symptoms score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash disability/symptoms score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change QuickDash disability/symptoms score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Work score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Work score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Work score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Sport/Music score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Sport/Music score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Sport/Music score
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
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 12 Feb 2024.
- Background: PubMed 12807327Brox JI, Lereim P, Merckoll E, Finnanger AM. Radiographic classification of glenohumeral arthrosis. Acta Orthop Scand. 2003 Apr;74(2):186-9. doi: 10.1080/00016470310013932.
- Background: PubMed 28535076Hangody L, Szody R, Lukasik P, Zgadzaj W, Lenart E, Dokoupilova E, Bichovsk D, Berta A, Vasarhelyi G, Ficzere A, Hangody G, Stevens G, Szendroi M. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.
- Background: PubMed 19945321Noel E, Hardy P, Hagena FW, Laprelle E, Goebel F, Faure C, Favard L, Gaudin P, Christ R, Baudot C, Dietl J, Goupille P. Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study. Joint Bone Spine. 2009 Dec;76(6):670-3. doi: 10.1016/j.jbspin.2009.10.008.
- Background: PubMed 28137554He WW, Kuang MJ, Zhao J, Sun L, Lu B, Wang Y, Ma JX, Ma XL. Efficacy and safety of intraarticular hyaluronic acid and corticosteroid for knee osteoarthritis: A meta-analysis. Int J Surg. 2017 Mar;39:95-103. doi: 10.1016/j.ijsu.2017.01.087. Epub 2017 Jan 27.
- Background: PubMed 16652426Petrella RJ, Petrella M. A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. J Rheumatol. 2006 May;33(5):951-6.
- Background: PubMed 25887932Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.
- Background: PubMed 30046992Smith C, Patel R, Vannabouathong C, Sales B, Rabinovich A, McCormack R, Belzile EL, Bhandari M. Combined intra-articular injection of corticosteroid and hyaluronic acid reduces pain compared to hyaluronic acid alone in the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1974-1983. doi: 10.1007/s00167-018-5071-7. Epub 2018 Jul 25.
- Background: PubMed 6833319Samilson RL, Prieto V. Dislocation arthropathy of the shoulder. J Bone Joint Surg Am. 1983 Apr;65(4):456-60.
- Background: PubMed 27252432Tammachote N, Kanitnate S, Yakumpor T, Panichkul P. Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. J Bone Joint Surg Am. 2016 Jun 1;98(11):885-92. doi: 10.2106/JBJS.15.00544.
- Background: PubMed 10512449Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.
- Background: PubMed 30502030Zhang B, Thayaparan A, Horner N, Bedi A, Alolabi B, Khan M. Outcomes of hyaluronic acid injections for glenohumeral osteoarthritis: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2019 Mar;28(3):596-606. doi: 10.1016/j.jse.2018.09.011. Epub 2018 Nov 28.
- Individual participant dataSharing planned: No
Related trials for Infiltration
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
RecruitingPhase 1/2
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Tumor Skin, Metastatic Melanoma
RecruitingPhase 1/2
A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
Select Advanced Solid Tumors
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.
Patrice Tétreault, MD FRCSC principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Hexacetonide and hyaluronic acid and Triamcinolone Hexacetonide in people with Infiltration and Shoulder Osteoarthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 12 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Fidaa Al-Shakfa, M.Sc, MBA (5148908000 ext. 26103, f.alshakfa.crchum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS score (time frame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration). 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 NCT05408065, which also lists 11 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 12 Feb 2024.