Bunion
Conditions
Brief summary
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
Interventions
DRUGKetorolac
30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
DRUGPlacebo
Placebo plus standard of care
Sponsors
American College of Foot and Ankle Surgeons
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Hallux abductus with bunion deformity * Adult patients as defined by \>=18 years old and \<= 65 years old * Subject has adequate perfusion, verified by the surgeon, which is defined by palpable pedal pulses * Subject has voluntarily signed and dated an informed consent form, approved by IRB, and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study * Subject agrees not to take any new medications, dietary supplements, or alternative therapies during the study period (approximately 12 weeks) * Subject is interested in participating in the study and willing to comply with the study protocol * Patient has pain related to a bunion deformity but pain-free metatarsalphalangeal joint (MTPJ) range of motion that is not functionally adapted * Adequate bone density to withstand a Kalish bunionectomy procedure * No frontal plane hallux deformity * Minimal abnormality of the PASA * Normal to minimally malaligned sagittal plane position of the first metatarsal * Failure of conservative treatment * General Pre-operative Radiographic Angle Criteria† - 10-15 degree IMA in rectus feet\* - 20-25 degree TAA in adducted feet\* - 15-20 degree IMA in rectus feet if wide metatarsal head width - 25-30 degree TAA in adducted feet if wide metatarsal head width IMA=intermetatarsal angle; TAA=total adductus angle \*If the pre-operative IMA is \<15 degree, only the IMA will be used pre-operatively. For IMA \>=15, the total adductus angle will be used †These are general guidelines and the width of the metatarsal as well as the presence of positional, structural, or combined first ray deformity may also influence procedure selection.
Exclusion criteria
* a history of an allergic-type reaction in response to exposure to aspirin, phenylacetic acid derivatives, or other NSAIDs * hypersensitivity to ketorolac tromethamine, or to any product component * any known bleeding risk or bleeding disorder, suspected or confirmed * history of or active cerebrovascular bleeding, suspected or confirmed * concomitant aspirin or NSAID use where the patient may not be advised to discontinue the medication during the study * concomitant pentoxifylline use * concomitant probenecid use * coronary artery bypass graft (CABG) surgery within one year of the procedure * any history of gastrointestinal bleeding/perforation, gastrointestinal ulcer, severe peptic ulcer disease, or severe inflammatory bowel disease * hemorrhagic diathesis, suspected or confirmed * incomplete intraoperative hemostasis * pre-operative serum creatinine \> 1.5 ml/dL or blood urea nitrogen level \> 22 mg/dL * any history of renal impairment or risk of renal failure due to volume depletion * Patients with a known allergy, contraindication and/or intolerance for oxycodone 5mg - acetaminophen 325 mg will be excluded from the study. * Patients with a known allergy, contraindication, and/or intolerance for the local anesthetic (bupivicaine) or any of the standardized intra-operative opioids and anti-emetics administered by the anesthesiologist * Patients with a history of fibromyalgia or opioid abuse * History of chronic regional pain syndrome or diagnosis of any chronic pain syndrome, patients requiring routine methadone or other opioids * Neuropathy or radiculopathy * Subject has alcohol or substance abuse, dementia, brain metastases, or other cognitive disorders that may interfere with pain assessment and the post-operative course outlined by the surgeon * American Society of Anesthesiologists (ASA) Physical Status class four or higher * women who are pregnant, planning on becoming pregnant, or breast feeding * presence of active local or systemic infection * subject has a myocardial infarction in the last twelve months • Patients who are not candidates for a Kalish bunionectomy due to the preoperative deformity as well as other study exclusions are: * Absent pedal pulses or ABI \< 0.9 and \> 1.2 * Concomitant midfoot and rearfoot procedures * Moderate to high abnormal PASA angles * Significant sagittal plane first metatarsal deformity * Moderate to severe osteoporosis as evaluated by preoperative radiographs and/or bone mineral density tests * Revision cases * History of previous infections, radiation treatment, or current infection related to the surgical site * History of previous trauma of the first metatarsal or first ray * Subject has known immunosuppression (HIV, recent chemotherapy, organ transplant) * Patients taking systemic steroid (patients taking less than 5 mg of prednisone, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids will not be excluded) * Subject has active malignancy, excluding cutaneous malignancies except melanoma Pregnancy Elective bunion surgery will not be performed if the patient is pregnant or planning on becoming pregnant during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | Post-Operative Day 2 | 18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed. |
| Osseous Healing | 3 months | Radiographic assessment by a blinded board certified radiologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Activity Recovery | up to 3 months | Functional Recovery Index |
| Adverse Events | 1 week | Comparison of adverse events between the two study arms |
| Quantity of Narcotic Medication | 1 week | Comparison of quantity of narcotic medication utilized within the two study arms |
Countries
United States
Participant flow
Recruitment details
18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo plus standard of care
Placebo: Placebo plus standard of care | 0 |
| Ketorolac 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Osseous Healing
Radiographic assessment by a blinded board certified radiologist
Time frame: 3 months
Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Primary
Post-Operative Pain
18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.
Time frame: Post-Operative Day 2
Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Secondary
Adverse Events
Comparison of adverse events between the two study arms
Time frame: 1 week
Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Secondary
Post-operative Activity Recovery
Functional Recovery Index
Time frame: up to 3 months
Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Secondary
Quantity of Narcotic Medication
Comparison of quantity of narcotic medication utilized within the two study arms
Time frame: 1 week
Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.