Clinical trial NCT07006168: Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation
Official title: Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Patella Fracture
Keywords: Intra-Articular analgesic injection
Pain relief
Open Reduction and Internal Fixation
Functional Recovery
Rehabilitation
Range of motion
Post-operative recovery
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be allocated to receive either Intra-articular Cocktail Injection (IA Cocktail) OR receive no Injection (Control).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* acute patella fracture requiring open reduction and internal fixation;
* able to consent to surgery;
* pre-morbid able to ambulate

Exclusion Criteria:

* open fracture;
* polytrauma;
* previous knee arthroplasty;
* history of chronic pain,
* insulin-dependent diabetes mellitus, or peptic ulcer disease;
* chronic users of glucocorticoids, immunosuppressants, or immune-modulating agents, or of strong opioids (e.g.: morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine);
* hepatitis B or C carrier;
* renal impairment (creatinine \[Cr\], \>200 mmol/L)

Primary outcomes:
measure: Pain as measured by Numerical Patient Reported Scale (NRPS)
timeFrame: Pre-op, Post-op Day 1 to 3
measure: Maximum Active Knee Flexion
timeFrame: At post-op Day 1 to 3
measure: Oral analgesics consumed
timeFrame: Post-operative 2 weeks period
measure: Tegner Lysholm Knee Score
timeFrame: Post-op Day 14
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Post-op Day 14
measure: 9-item Quality of Recovery Score (QoR-9 Score)
timeFrame: Post-op Day 1 to 3
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Time to radiological bony union
timeFrame: Through study completion, an average of 1 year
measure: Incidence of Complications
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: Dept of Orthopaedics and Traumatology, Queen Mary Hospital
name: Christian Fang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.