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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

15mo left

Started Nov 2024

Typical duration for phase_4

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.7 years study duration

Study Progress55%

Nov 2024Jul 2027

Study Start

First participant enrolled

November 1, 2024

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2025

Completed

21 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 5, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

May 15, 2025

Last Update Submit

May 27, 2025

Conditions

Patella Fracture

Keywords

Intra-Articular analgesic injectionPain reliefOpen Reduction and Internal FixationFunctional RecoveryRehabilitationRange of motionPost-operative recovery

Outcome Measures

Primary Outcomes (6)

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)
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

Secondary Outcomes (3)

Length of hospital stay
Through study completion, an average of 1 year
Time to radiological bony union
Through study completion, an average of 1 year
Incidence of Complications
Through study completion, an average of 1 year

Study Arms (2)

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.

Drug: Ketorolac 15mgDrug: Triamcinolone Acetonide 40mgDrug: Ropivacaine HCL 1% 15mlDrug: 0.9 % Normal Saline 35mlDrug: Adrenaline 1:1000 0.5ml

No Injection

NO INTERVENTION

No injection will be given to the patient.

Interventions

Ketorolac 15mgDRUG

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.