Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07006168

Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial

Led by The University of Hong Kong · Updated on 2025-06-05

56

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an intra-articular analgesic cocktail injection for patients who have undergone surgery to fix a fractured patella, the kneecap. The study aims to compare pain relief and functional recovery between patients who receive this injection during surgery and those who do not. Additionally, the study looks at whether this injection can reduce hospital stays and related complications, which could lower healthcare costs. This study is a single-center, double-blinded, randomized control trial where participants are assigned to one of two groups. One group receives an injection of a cocktail containing Ketorolac 15mg, Ropivacaine 1% 15ml, Normal Saline 35ml, Adrenaline 0.5ml, and Triamcinolone Acetonide 40mg directly into the surgical site after fracture fixation. The other group does not receive any injection. The total volume of the injected cocktail is about 50ml. The trial compares outcomes between these two groups. Participants will be monitored for pain using a Numerical Patient Reported Scale before surgery and during the first three days after surgery. Researchers will also assess knee movement, oral pain medication use over two weeks, and knee function scores at two weeks post-operation. Quality of recovery will be measured in the first three days after surgery. Secondary outcomes include length of hospital stay, time for bone healing seen in X-rays over about a year, and any complications. The study lasts for roughly one year for each participant, with ongoing safety and recovery assessments.

CONDITIONS

Brief Title

Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute patella fracture requiring open reduction and internal fixation
  • Able to consent to surgery
  • Able to walk before the injury
Not Eligible

You will not qualify if you...

  • Open fracture
  • Multiple trauma injuries
  • Previous knee replacement surgery
  • History of chronic pain
  • Insulin-dependent diabetes mellitus
  • Peptic ulcer disease
  • Chronic use of glucocorticoids, immunosuppressants, immune-modulating agents, or strong opioids
  • Hepatitis B or C carrier
  • Renal impairment with creatinine over 200 mmol/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day and immediate post-operative period

Participants undergo open reduction and internal fixation surgery for patella fracture. Those in the intervention group receive an intra-articular cocktail injection into the surgical site during surgery, while the control group does not receive an injection.

1 surgical visit and hospital stay

Post-operative Follow-up

Duration - 2 weeks

Participants are observed and assessed for post-operative pain relief, knee function, and recovery over the following two weeks.

Daily visits for post-op Day 1 to 3 and follow-up visits up to Day 14

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for length of hospital stay, time to bone healing, and incidence of complications for up to approximately one year after surgery.

Periodic visits during the year depending on recovery

Trial Site Locations

Total: 1 location

1

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Actively Recruiting

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Research Team

C

Christian FANG

C

Christian Fang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial