Total Hip Replacement
Conditions
Brief summary
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
Interventions
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su. * Patients between the age of 50 and 90
Exclusion criteria
* Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively * Patients who are smokers * Patients who have diabetes * Patients who are \<50 and \>90 years of age * Patients with history of prior difficulties tolerating corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Prothrombin Fragment 1 and 2 (PF 1.2) | First 24 hours after surgery |
| Plasmin-a 2 Antiplasmin Complex (PAP) | First 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | Participants will be followed from the time of surgery until discharge, expected average of 3-5 days | The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. |
| Desmosine Level (Marker of Lung Injury) | Participants will be followed from the time of surgery until discharge, expected average of 3-5 days | The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. |
| Pain at 3 Months Post-op | 3 months postoperatively | At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Control group
Placebo (for Prednisone) | 14 |
| Prednisone/Hydrocortisone Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Prednisone/Hydrocortisone | Total |
|---|---|---|---|
| Age, Continuous | 65.13 years STANDARD_DEVIATION 7.16 | 66.21 years STANDARD_DEVIATION 8.8 | 65.66 years STANDARD_DEVIATION 7.87 |
| Body mass index | 26.04 kg/(m^2) STANDARD_DEVIATION 3.92 | 28.03 kg/(m^2) STANDARD_DEVIATION 4.86 | 27.00 kg/(m^2) STANDARD_DEVIATION 4.43 |
| Gender Female | 8 Participants | 9 Participants | 17 Participants |
| Gender Male | 6 Participants | 4 Participants | 10 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Plasmin-a 2 Antiplasmin Complex (PAP)
Time frame: First 24 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasmin-a 2 Antiplasmin Complex (PAP) | Wound Closure | 1361.23 mcg/L | Standard Deviation 527.7 |
| Placebo | Plasmin-a 2 Antiplasmin Complex (PAP) | 6 hours postoperatively | 2283.18 mcg/L | Standard Deviation 711 |
| Placebo | Plasmin-a 2 Antiplasmin Complex (PAP) | 4 hours postoperatively | 2251.33 mcg/L | Standard Deviation 680.1 |
| Placebo | Plasmin-a 2 Antiplasmin Complex (PAP) | 24 hours postoperatively | 996.39 mcg/L | Standard Deviation 251.1 |
| Placebo | Plasmin-a 2 Antiplasmin Complex (PAP) | Baseline | 924.67 mcg/L | Standard Deviation 324.7 |
| Prednisone/Hydrocortisone | Plasmin-a 2 Antiplasmin Complex (PAP) | 24 hours postoperatively | 914.16 mcg/L | Standard Deviation 186.6 |
| Prednisone/Hydrocortisone | Plasmin-a 2 Antiplasmin Complex (PAP) | Baseline | 1011.17 mcg/L | Standard Deviation 212.3 |
| Prednisone/Hydrocortisone | Plasmin-a 2 Antiplasmin Complex (PAP) | Wound Closure | 2251.33 mcg/L | Standard Deviation 680.1 |
| Prednisone/Hydrocortisone | Plasmin-a 2 Antiplasmin Complex (PAP) | 4 hours postoperatively | 2455.71 mcg/L | Standard Deviation 458 |
| Prednisone/Hydrocortisone | Plasmin-a 2 Antiplasmin Complex (PAP) | 6 hours postoperatively | 2379.57 mcg/L | Standard Deviation 395.3 |
Primary
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Time frame: First 24 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | Wound Closure | 778.33 pmol/mL | Standard Deviation 353.7 |
| Placebo | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 6 hours postoperatively | 1175.71 pmol/mL | Standard Deviation 400.9 |
| Placebo | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 4 hours postoperatively | 1306.76 pmol/mL | Standard Deviation 445.4 |
| Placebo | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 24 hours postoperatively | 356.79 pmol/mL | Standard Deviation 94.9 |
| Placebo | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | Baseline | 334.15 pmol/mL | Standard Deviation 193.9 |
| Prednisone/Hydrocortisone | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 24 hours postoperatively | 422.61 pmol/mL | Standard Deviation 191.6 |
| Prednisone/Hydrocortisone | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | Baseline | 298.12 pmol/mL | Standard Deviation 124.6 |
| Prednisone/Hydrocortisone | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | Wound Closure | 619.21 pmol/mL | Standard Deviation 154.9 |
| Prednisone/Hydrocortisone | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 4 hours postoperatively | 1138.65 pmol/mL | Standard Deviation 435.7 |
| Prednisone/Hydrocortisone | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | 6 hours postoperatively | 1032.52 pmol/mL | Standard Deviation 466.8 |
Secondary
Desmosine Level (Marker of Lung Injury)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Time frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Population: Desmosine levels were not analyzed.
Secondary
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Time frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | Wound closure | 4.46 picograms/milliliter | Standard Deviation 4.2 |
| Placebo | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 6 hours postoperatively | 115.17 picograms/milliliter | Standard Deviation 56.1 |
| Placebo | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 4 hours postoperatively | 89.21 picograms/milliliter | Standard Deviation 52.1 |
| Placebo | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 24 hours postoperatively | 176.79 picograms/milliliter | Standard Deviation 91.4 |
| Placebo | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | Baseline | 2.98 picograms/milliliter | Standard Deviation 2.3 |
| Prednisone/Hydrocortisone | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 24 hours postoperatively | 68.51 picograms/milliliter | Standard Deviation 45.8 |
| Prednisone/Hydrocortisone | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | Baseline | 5.69 picograms/milliliter | Standard Deviation 8.7 |
| Prednisone/Hydrocortisone | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | Wound closure | 4.47 picograms/milliliter | Standard Deviation 6.3 |
| Prednisone/Hydrocortisone | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 4 hours postoperatively | 56.72 picograms/milliliter | Standard Deviation 27.6 |
| Prednisone/Hydrocortisone | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | 6 hours postoperatively | 64.4 picograms/milliliter | Standard Deviation 33.7 |
Secondary
Pain at 3 Months Post-op
At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain at 3 Months Post-op | 0.92 units on a scale | Standard Deviation 0.76 |
| Prednisone/Hydrocortisone | Pain at 3 Months Post-op | 0.54 units on a scale | Standard Deviation 0.66 |