An interventional study of Warmed Arthroscopic Fluids and Room Temperature Arthroscopic Fluids in Femoro Acetabular Impingement and Pain, Postoperative, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
Among 37 studies in Femoracetabular Impingement with a site in United States — 10 open to participants now, 15 under way, 1 of them phase 3. Femoracetabular Impingement · United States.
Among the 37 studies in Femoracetabular Impingement with a site in United States, this one is the 23rd largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2018, is one of 18 with no phase, and was the 16th registered.
116 studies on the registry are indexed under Femoracetabular Impingement; 37 are open to participants now.
Browse Femoracetabular Impingement studies →10 of the 37 studies in Femoracetabular Impingement with a site in United States are open now. Recruiting first, the newest first:
American Hip Institute · Sites in United States
Ages 18–60
University of Missouri-Columbia · Sites in United States
Ages 18+
Henry Ford Health System · Sites in United States
Ages 18–89
Massachusetts General Hospital · Sites in United States
Ages 18+
Rush University Medical Center · Sites in United States
Ages 18–40 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 19 Femoracetabular Impingement studies recruiting now, 6 (32%) set no upper age limit and 11 (58%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
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37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 2 · Phase 4 6
First in 2012; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 73 across 70 interventional studies indexed under Femoracetabular Impingement.
Median enrollment 62 across the 28 interventional studies, 88 across the 9 observational. Of the 18 that completed or were terminated, 9 (50%) have results posted.
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1 of 37 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 3 studies filed under Femoracetabular Impingement — fewer than ten, so there is no comparison to draw.
5 of the studies in Femoracetabular Impingement with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06003101Phase 3Massachusetts General HospitalEffect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies | 2027-08-30 |
| NCT07037888Henry Ford Health SystemEfficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy | 2026-12 |
| NCT02664337Duke UniversityConjoint Analysis of Patient Preferences in Joint Interventions | 2027-07 |
| NCT04094701Rush University Medical CenterHip Arthroscopy Postoperative Opioid Demands | 2027-11 |
| NCT04113759Rush University Medical CenterBlood Flow Restriction Following Hip Arthroscopy | 2027-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 37 studies in Femoracetabular Impingement with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes post-operatively in the warmed fluid group compared to the control group. Secondary outcome measures to be collected will include VAS scores 60 minutes after surgery and on post-operative day (POD) one. Additionally, the investigators will collect post-operative temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing in PACU and at the two-week follow up visit.
In the last two decades, hip arthroscopy for the treatment of femoral acetabular impingement has increased rapidly. Currently, over 30k hip scopes are performed annually in the United States (incidence 1.06 per 10K). Due to anatomical differences, hip arthroscopy procedures have the potential for significant fluid extravasation when compared to knee arthroscopy. A 2011 study on hip arthroscopy showed on average 9.68 liters of fluid were used for a standard hip procedure; of that 1.13 liters absorbed into the surrounding soft tissues. A recent systematic review and meta-analysis showed warming of arthroscopic fluids significantly decreased the risk of hypothermia during hip arthroscopy. Additionally, active warming has been shown to decrease the rate of surgical site infection during numerous procedures. In total knee arthroplasty patients, a forced air warming gown significantly reduced narcotic pain consumption compared to standard care. However, the benefits of active warming for decreasing post-operative pain has not been studied in hip arthroscopy patients. Specifically, the investigators were interested in the roll the pre-warming arthroscopic fluid plays in post-operative pain after hip arthroscopy. The purpose of this study is to see if pre-warming of arthroscopic fluid reduces immediate post-surgical pain and narcotic consumption in hip arthroscopy patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.
Procedure: Warmed Arthroscopic Fluids
Arthroscopic fluids will be kept at room temperature and will not be warmed per current standard of care. Temperature will be measured in real time.
Procedure: Room Temperature Arthroscopic Fluids
Warmed Arthroscopic Fluids
Room Temperature Arthroscopic Fluids
Changes in Visual Analog Score
A Visual Analog Score (VAS) will be measured pre-operatively, 30 and 60 minutes after patient arrival in the post-anesthesia care unit (PACU). Additionally, VAS will be collected in the clinic on post-operative day (POD) 1 and POD 14. The visual analog scale measures subject reported pain on a scale of 0-100 with a score of 0 indicating no pain and 100 indicating the worst pain possible.
Time frame: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.
Changes in Temperature
Subject core temperature will be collected 30 and 60 minutes after arrival in PACU. The method for collection will be done via current standard of care.
Time frame: 30-60 minutes after after completion of surgery
Morphine Equivalent Dosage (MED)
Morphine equivalent dose (MED) will be calculated in PACU and at the subject's routine two-week post-operative appointment via medication reconciliation.
Time frame: After completion of surgery and at the 2-week Post Operative Visit
Hip Outcomes Score (HOS)
The HOS has been validated in patients with femoral acetabular impingement and has two subscales (Activities of Daily Living and Sports). The ADL subscale contained 19 items pertaining to basic daily activities, and the sports subscale contained 9 items pertaining to higher-level activities. The ADL and sports subscales are scored separately. The response to each item on the ADL subscale is scored from 4 to 0, with 4 indicating "no difficulty" and 0 indicating "unable to do." The scores for each of the items are added together to obtain a total. The total number of items with a response is multiplied by 4 to obtain the highest potential score. The item score total is divided by the highest potential score. This value is then multiplied by 100 to obtain a percentage. The sports subscale is scored in a similar manner, with the highest potential score being 36. A higher score represents a higher level of physical function.
Time frame: Pre-operatively
Veterans Rand 12 (VR-12)
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life and to estimate disease. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). PCS and MCS summary scores are standardized using a t-score transformation and normed to a U.S. population of a score of 50 and a standard deviation of 10. The subscales are not combined or averaged for a total score. A Higher score represents a higher function.
Time frame: Pre-Operatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Aug 2021, 41 months.
Of 41 non-industry interventional studies with no phase under Femoracetabular Impingement, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 79. This study's 41 months is close to that.
Counting every sponsor, half of 42 studies reached it within 41 months; a quarter within 28 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →