An interventional study of Exercise and Manual Therapy in Femoroacetabular Impingement, sponsored by Duke University. Terminated at 3 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Duke University · Not applicable, Interventional, and Other
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 24th largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2017, is one of 18 with no phase, and was the 14th 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 60 Years · all sexes · no healthy volunteers.
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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 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 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:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University 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 |
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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.
A total of 63 participants will be recruited through 3 local surgeons in Durham, North Carolina after distinctive differential diagnostic methods, all with extensive expertise in intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to participate in the trial by providing information to the recipient. Potential participants that do not contact project team members will be contacted by phone if they do not respond to the initial invitation. Potential participants will be initially screened by telephone interview, followed by a clinical examination to confirm study eligibility. The blinded researchers will obtain informed consent and will perform outcome assessments
Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive six weeks of conservative physical therapy intervention and 2) measure the effect of baseline expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six weeks.
FAI Syndrome is a morphological hip condition that can cause hip/groin pain and impaired performance.1 FAI Syndrome is caused by abnormal morphology of the femoral head (referred to as cam FAI Syndrome), excessive acetabular coverage of the femoral head (referred to as pincer FAI Syndrome) or a combination of the two (mixed FAI Syndrome).2 Not only can FAI Syndrome give rise to symptoms and impair function, the repetitive bony contact can also lead to a cascade of structural damage including tearing at the chondrolabral junction, full thickness cartilage delamination, and potentially hip osteoarthritis.
Presently, there is uncertainty involving the best treatment approach for symptomatic FAI Syndrome.2 The principal two management options are 1) physical therapy management of impairments and function and/or 2) surgery. Although presently, both modalities have been shown to improve symptoms in the short term,2 surgery is by far the most commonly incorporated approach.1, The incidence of the surgery has notably increased in recent years. There has been an 18-fold increase in surgical procedures for FAI Syndrome between 1999 and 2009, varying by geographic region in the USA.3
As an elective procedure, surgery for correction of FAI Syndrome is likely influenced by patients' perspectives and expectations of outcome.4 The extent to which these expectations influence specific treatment choices, as well as subsequent outcomes is currently unclear, although recent findings suggest that across various pathologies both patients5 and clinicians6 rarely have accurate expectations of treatment benefits or harms.
Non-operative, conservative treatments may have a role in managing FAI Syndrome to alleviate symptoms, potentially resulting in postponement or avoidance of surgery. Bony morphological changes can be present without symptoms, and nearly all participants with symptomatic FAI Syndrome undergo a variable asymptomatic period in the presence of structural FAI Syndrome. Recent studies have been hampered by retrospective and case cohort design, very small sample sizes, short-term follow up, and self-report measures only.4 A recent systematic review stated "although the available literature with experimental data is limited, there is a suggestion that physical therapy and activity modification confer some benefit to patients. Non-operative treatment regimens, particularly physical therapy, need to be evaluated more extensively and rigorously".6 Further, it is well known that patient expectations can mediate outcomes. Those who have high expectations about the potential benefit of the conservative approach are more likely to experience improvements. Conversely, those who have low expectations are more likely to fail to see improvement.
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:
Exercise and manual therapy
Other: Exercise · Other: Manual Therapy
A prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations will be provided as a home program. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Participants will be seen for 3 visits over 6 weeks and a final visit 1 year post-surgery for those electing to undergo surgery. The interventions will consist of progressive exercise (PE) in two phases with general instruction guidelines. The assigned program will be tailored per each participant's clinical presentation and progressed based on response to exercise load. The researcher will instruct, review and supervise each program initially and, at follow-up visits; as well as monitor progress, re-enforce treatment strategies and modify the respective program accordingly. Each participant will receive a home program manual as well as a program log.
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
Fulfillment of expectations with conservative care
fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
Time frame: 6 weeks post study initiation
Fulfillment of expectations with surgery
fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire
Time frame: 1 year post-surgery
Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
patient expectations of care
Time frame: baseline, 6 weeks and 1 year post-surgery
Expectations of conservative care
Expectations of conservative care as measured by expectation survey
Time frame: baseline
Change in Expectations of surgery as measured by expectation survey
Time frame: baseline and 6 weeks
Change in Reasons for surgery
patient reasons on why choosing surgery
Time frame: baseline and 6 weeks
Change in Patient Acceptable Symptom State (PASS)
PASS
Time frame: 6 weeks and 1 year post-surgery
Change in Numeric pain rating scale (NPRS)
Time frame: baseline, 2 weeks, 6 weeks and 1 year
Change in Global Rating of Change Score (GRoC)
GRoC
Time frame: 2 weeks, 6 weeks and 1 year post-surgery
Change in Hip and Groin Outcome Score (HAGOS)
Patient reported outcome measure relative to hip and groin pain
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Single Leg Squat (Maximum ROM until onset of pain)
single leg squat performance
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Bilateral Squat (Maximum ROM until onset of pain)
bilateral leg squat performance
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Tegner Activity Scale
Tegner Activity Scale
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Adverse events
any adverse events encountered
Time frame: baseline, 2 weeks, 6 weeks and 1 year post-surgery
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Jul 2018, 8 months.
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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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