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CompletedNCT04761302Updated Mar 4, 2025Results posted

Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures

A Phase 4 interventional study of Intravenous ketorolac and oral acetaminophen and Intravenous morphine and oral oxycodone in Femur Fracture and Tibial Fractures, sponsored by University of Puerto Rico. Completed at 1 site in Puerto Rico. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by University of Puerto Rico · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Study summary

The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

Read the detailed description

The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).

02

Conditions studied

  • Femur Fracture
  • Tibial Fractures

Keywords

  • Opioid use
  • Post-operative pain
  • Analgesic use
  • Femur fracture
  • Tibia fracture
  • Intramedullary Nailing
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 167 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Puerto Rico is the lead sponsor of 45 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with tibial and femoral shaft fractures
  2. Patients undergoing intramedullary nailing
  3. Willing to participate in the protocol

Exclusion criteria

Exclusion Criteria:

  1. Chronic pain disorder (daily use of oral opioids)
  2. Allergy or hypersensitivity to non steroid anti-inflammatory drug
  3. Impaired renal, cardiac, or hepatic function
  4. History of gastrointestinal bleeding or substance abuse
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen

    Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.

    Drug: Intravenous ketorolac and oral acetaminophen

  • Active comparator
    Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone

    Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

    Drug: Intravenous morphine and oral oxycodone

  • Experimental
    Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen

    Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.

    Drug: Intravenous ketorolac and oral acetaminophen

  • Active comparator
    Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone

    Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

    Drug: Intravenous morphine and oral oxycodone

Interventions

  • DrugIntravenous ketorolac and oral acetaminophen

    ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group

  • DrugIntravenous morphine and oral oxycodone

    Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

06

What researchers measure

Primary outcomes

  1. 12hrs VAS Pain Scores

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

    Time frame: Measured at postoperative hour 12

  2. 24hrs VAS Pain Score

    Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)

    Time frame: Measured at postoperative hour 24

  3. 36hrs VAS Pain Scores

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

    Time frame: Measured at postoperative hour 36

  4. 48hrs VAS Pain Scores

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

    Time frame: Measured at postoperative hour 48

  5. 12hrs MME

    Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)

    Time frame: Measured at postoperative hour 12

  6. 24hrs MME

    Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)

    Time frame: Measured at postoperative hour 24

  7. 36hrs MME

    Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)

    Time frame: Measured at postoperative hour 36

  8. 48hrs MME

    Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)

    Time frame: Measured at postoperative hour 48

Secondary outcomes

  1. Hospital Length of Stay

    Time from intervention to discharge

    Time frame: Determined by discharge date

07

Results

Posted Mar 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Started52442942
Completed52442942
Not completed0000

Outcome measures

Primary12hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame:
Measured at postoperative hour 12
Reported as:
Mean · score on a scale
12hrs VAS Pain Scores
score on a scaleGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
12hrs VAS Pain Scores7.6 ± 2.207.9 ± 2.017.3 ± 2.57.2 ± 2.0
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.215 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.445 (A priori threshold for statistical significance: \<0.05)
Primary24hrs VAS Pain Score

Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)

Time frame:
Measured at postoperative hour 24
Reported as:
Mean · score on a scale
24hrs VAS Pain Score
score on a scaleGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
24hrs VAS Pain Score4.9 ± 2.55.9 ± 2.65.4 ± 2.65.1 ± 2.4
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.041 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.300 (A priori threshold for statistical significance: \<0.05)
Primary36hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame:
Measured at postoperative hour 36
Reported as:
Mean · score on a scale
36hrs VAS Pain Scores
score on a scaleGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
36hrs VAS Pain Scores4.9 ± 2.55.63 ± 2.35.3 ± 1.85.6 ± 2.3
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.12 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.359 (A priori threshold for statistical significance: \<0.05)
Primary48hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame:
Measured at postoperative hour 48
Reported as:
Mean · score on a scale
48hrs VAS Pain Scores
score on a scaleGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
48hrs VAS Pain Scores3.6 ± 2.014.3 ± 2.64.0 ± 1.63.4 ± 2.2
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.083 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.152 (A priori threshold for statistical significance: \<0.05)
Primary12hrs MME

Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)

Time frame:
Measured at postoperative hour 12
Reported as:
Mean · Morphine Milligram Equivalents (MME)
12hrs MME
Morphine Milligram Equivalents (MME)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
12hrs MME2.9 ± 7.58.5 ± 10.12.9 ± 4.512.1 ± 11.6
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.002 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = <0.001 (A priori threshold for statistical significance: \<0.05)
Primary24hrs MME

Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)

Time frame:
Measured at postoperative hour 24
Reported as:
Mean · Morphine Milligram Equivalents (MME)
24hrs MME
Morphine Milligram Equivalents (MME)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
24hrs MME9.2 ± 18.621.49 ± 22.410.4 ± 13.628.8 ± 20.6
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.002 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = <0.001 (A priori threshold for statistical significance: \<0.05)
Primary36hrs MME

Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)

Time frame:
Measured at postoperative hour 36
Reported as:
Mean · Morphine Milligram Equivalents (MME)
36hrs MME
Morphine Milligram Equivalents (MME)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
36hrs MME14.1 ± 25.929.5 ± 29.915.7 ± 15.936.6 ± 29.1
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.004 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = <0.001 (A priori threshold for statistical significance: \<0.05)
Primary48hrs MME

Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)

Time frame:
Measured at postoperative hour 48
Reported as:
Mean · Morphine Milligram Equivalents (MME)
48hrs MME
Morphine Milligram Equivalents (MME)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
48hrs MME18.3 ± 33.337.2 ± 37.820.1 ± 21.048.0 ± 35.6
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.006 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = <0.001 (A priori threshold for statistical significance: \<0.05)
SecondaryHospital Length of Stay

Time from intervention to discharge

Time frame:
Determined by discharge date
Reported as:
Mean · Days
Hospital Length of Stay
DaysGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Hospital Length of Stay1.9 ± 0.612.00 ± 0.891.8 ± 0.51.9 ± 1.1
Statistical analysis
  • Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.354 (A priori threshold for statistical significance: \<0.05)
  • Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone · t-test, 2 sided · p = 0.455 (A priori threshold for statistical significance: \<0.05)

Adverse events

Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen0/52 (0%)2/52 (3.8%)0/52 (0%)
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone0/46 (0%)3/46 (6.5%)0/46 (0%)
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen0/29 (0%)7/29 (24.1%)0/29 (0%)
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone0/42 (0%)8/42 (19%)0/42 (0%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Delayed UnionMusculoskeletal and connective tissue disorders0/520/465/296/42
Non-UnionMusculoskeletal and connective tissue disorders2/523/462/292/42

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Median31 (23 to 42)40 (27 to 60)31 (23 to 42)40 (27 to 60)36 (24 to 55)
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Female71061336
Male45342329131
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Count of participants————0
Body Mass Index (BMI)
Body Mass Index (BMI)(Kg/m^2)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Mean26.6 ± 5.9026.9 ± 6.2127.1 ± 7.126.7 ± 6.226.8 ± 6.3
Smoker status
Smoker status(Participants)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Smoker131261344
Non-smoker39322329123
Diabetes Status
Diabetes Status(Participants)Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneGroup 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral AcetaminophenGroup 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral OxycodoneTotal
Yes553821
No47392634146
08

Study locations

1 site
  • University District Hospital
    San Juan, 00936, Puerto Rico
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 6, 2021
  • Informed consent form · Oct 14, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04761302
Lead sponsor
University of Puerto Rico
Responsible party
Sponsor
First posted
Feb 18, 2021
Start date
Apr 18, 2021
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Results posted
Mar 4, 2025
Last update
Mar 4, 2025

Study contacts

Luis F. Lojo-Sojo, MD
principal investigator · Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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