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The objective of this study is to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients, by comparing post-operative pain relief and functional recovery among study subjects who received the injection and those who did not receive the injection. Secondary objective is to demonstrate the health economic effects of intra-articular analgesics cocktail injection by reducing length of hospital stay and reducing bed-stay related complications.
This is a single-centre, double-blinded, randomised control trial that evaluates the efficacy of intra-articular analgesics cocktail injection in post-operative pain relief and functional recovery for fractured patella fixation patients. The recruited study subjects will be randomised to the two study groups respectively in a 1:1 randomisation ratio.
Patella is the largest sesamoid bone in the human body, it acts as the fulcrum of our knee extensor apparatus and is important during the gait cycle. Patella fracture commonly occurs after a fall on a flexed knee. Treatment can be conservative or surgical with open reduction and internal fixation. Patients often experience significant pain around the knee post-operatively, limiting their walking ability and hindering their rehabilitation. As a result, total hospital stay will be prolonged, leading to hospital stay-related morbidity and additional healthcare economic burden.
Previous studies have shown that the use of an analgesic cocktail injection in arthroplasty cases can significantly reduce early postoperative pain and provide better early motion. The cocktail regime is as follows for a unilateral joint:
Ketoralac 15mg Ropivacaine 1% 15ml 0.9% Normal Saline 35ml Adrenaline 1:1000 0.5ml Stacort-A Triamcinolone Acetonide 40mg Total Cocktail Volume ~50ml
After fracture fixation, patients in the intervention group will receive an intra-articular injection of the above analgesic cocktail, while patients in the control group will not receive an injection.
Herein this study, the investigators hope to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-Articular Cocktail Injection | Experimental | After fixation, an intra-articular cocktail injection is injected into the surgical site. The intra-articular cocktail regime: Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg. The total cocktail volume is approximately 50ml. |
|
| No Injection | No Intervention | No injection will be given to the patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac 15mg | Drug | An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as measured by Numerical Patient Reported Scale (NRPS) | Numerical Patient Reported Scale (NRPS), 0 (no pain) to 10 (worst pain imaginable) | Pre-op, Post-op Day 1 to 3 |
| Maximum Active Knee Flexion | The patient's Knee flexion is measured by a physiotherapist | At post-op Day 1 to 3 |
| Oral analgesics consumed | The level of the analgesic consumed (non-opioids, weak opioids, strong opioids), and the frequency of consumption | Post-operative 2 weeks period |
| Tegner Lysholm Knee Score | The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor. | Post-op Day 14 |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | Post-op Day 14 |
| 9-item Quality of Recovery Score (QoR-9 Score) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | The number of days the patient was hospitalised | Through study completion, an average of 1 year |
| Time to radiological bony union | X-rays will be taken at different follow-up intervals (post-op 2 weeks, 6 weeks, 3 months, 6 months, 12 months). The X-rays will be assessed for bony union at the surgical site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian FANG | Contact | +852 22554581 | cfang@hku.hk | |
| Christian Fang | Contact | +852 22554581 | cfang@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Christian Fang | Dept of Orthopaedics and Traumatology, Queen Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital, The University of Hong Kong | Recruiting | Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38592262 | Background | Baid M, Narula S, Manara JR, Blakeney W. Evolution in the Management of Patella Fractures. J Clin Med. 2024 Feb 29;13(5):1426. doi: 10.3390/jcm13051426. | |
| 23955187 | Background | Petrie J, Sassoon A, Langford J. Complications of patellar fracture repair: treatment and results. J Knee Surg. 2013 Oct;26(5):309-12. doi: 10.1055/s-0033-1353990. Epub 2013 Aug 16. |
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Anonymized dataset to be included as supplementary data in the final publication
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Additional information available upon reasonable request of principal investigator
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Patients will be allocated to receive either Intra-articular Cocktail Injection (IA Cocktail) OR receive no Injection (Control).
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| Triamcinolone Acetonide 40mg | Drug | An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery. |
|
| Ropivacaine HCL 1% 15ml | Drug | An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery. |
|
| 0.9 % Normal Saline 35ml | Drug | An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery. |
|
| Adrenaline 1:1000 0.5ml | Drug | An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery. |
|
The QoR-9 has 9 questions evaluating the quality of recovery after surgery and anaesthesia. It is a patient-rated score ranging from 0 (worst) to 2 (best). |
| Post-op Day 1 to 3 |
| Through study completion, an average of 1 year |
| Incidence of Complications | Complications such as fracture site infection, loss of reduction, non-union, and malunion will be assessed and recorded | Through study completion, an average of 1 year |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D000092462 | Patella Fracture |
| ID | Term |
|---|---|
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D014222 | Triamcinolone Acetonide |
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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