Femoroacetabular Impingement Clinical Trial
Official title:
The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome
Verified date | June 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Individuals age 18 to 60 years, - diagnosed with FAI by an orthopedic surgeon and exhibiting - hip/groin symptoms for at least 3 months (symptomatic); and - signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina. Exclusion Criteria: - subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2; - have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures; - exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph - are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group; - are unable to understand English. |
Country | Name | City | State |
---|---|---|---|
United States | Duke Orthopaedic Clinic | Durham | North Carolina |
United States | Duke Orthopaedic Clinic Page Road | Durham | North Carolina |
United States | Duke Sports Science Institute | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Ayeni O, Chu R, Hetaimish B, Nur L, Simunovic N, Farrokhyar F, Bedi A, Bhandari M. A painful squat test provides limited diagnostic utility in CAM-type femoroacetabular impingement. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):806-11. doi: 10.1007/s00167-013-2668-8. Epub 2013 Sep 26. — View Citation
Beck M, Leunig M, Parvizi J, Boutier V, Wyss D, Ganz R. Anterior femoroacetabular impingement: part II. Midterm results of surgical treatment. Clin Orthop Relat Res. 2004 Jan;(418):67-73. — View Citation
Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4. — View Citation
Cormier S, Lavigne GL, Choinière M, Rainville P. Expectations predict chronic pain treatment outcomes. Pain. 2016 Feb;157(2):329-38. doi: 10.1097/j.pain.0000000000000379. — View Citation
Diamond LE, Dobson FL, Bennell KL, Wrigley TV, Hodges PW, Hinman RS. Physical impairments and activity limitations in people with femoroacetabular impingement: a systematic review. Br J Sports Med. 2015 Feb;49(4):230-42. doi: 10.1136/bjsports-2013-093340. Epub 2014 Sep 22. Review. — View Citation
Hoffmann TC, Del Mar C. Clinicians' Expectations of the Benefits and Harms of Treatments, Screening, and Tests: A Systematic Review. JAMA Intern Med. 2017 Mar 1;177(3):407-419. doi: 10.1001/jamainternmed.2016.8254. Review. — View Citation
Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016. Review. — View Citation
Kemp JL, Makdissi M, Schache AG, Pritchard MG, Pollard TC, Crossley KM. Hip chondropathy at arthroscopy: prevalence and relationship to labral pathology, femoroacetabular impingement and patient-reported outcomes. Br J Sports Med. 2014 Jul;48(14):1102-7. doi: 10.1136/bjsports-2013-093312. Epub 2014 Mar 21. — View Citation
Reiman MP, Thorborg K, Hölmich P. Femoroacetabular Impingement Surgery Is on the Rise-But What Is the Next Step? J Orthop Sports Phys Ther. 2016 Jun;46(6):406-8. doi: 10.2519/jospt.2016.0605. — View Citation
Thorborg K, Hölmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937. Erratum in: Br J Sports Med. 2011 Jul;45(9):742. — View Citation
Wall PD, Fernandez M, Griffin DR, Foster NE. Nonoperative treatment for femoroacetabular impingement: a systematic review of the literature. PM R. 2013 May;5(5):418-26. doi: 10.1016/j.pmrj.2013.02.005. Epub 2013 Feb 16. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fulfillment of expectations with conservative care | fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations' | 6 weeks post study initiation | |
Primary | Fulfillment of expectations with surgery | fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire | 1 year post-surgery | |
Secondary | Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) | patient expectations of care | baseline, 6 weeks and 1 year post-surgery | |
Secondary | Expectations of conservative care | Expectations of conservative care as measured by expectation survey | baseline | |
Secondary | Change in Expectations of surgery as measured by expectation survey | baseline and 6 weeks | ||
Secondary | Change in Reasons for surgery | patient reasons on why choosing surgery | baseline and 6 weeks | |
Secondary | Change in Patient Acceptable Symptom State (PASS) | PASS | 6 weeks and 1 year post-surgery | |
Secondary | Change in Numeric pain rating scale (NPRS) | baseline, 2 weeks, 6 weeks and 1 year | ||
Secondary | Change in Global Rating of Change Score (GRoC) | GRoC | 2 weeks, 6 weeks and 1 year post-surgery | |
Secondary | Change in Hip and Groin Outcome Score (HAGOS) | Patient reported outcome measure relative to hip and groin pain | baseline, 6 weeks and 1 year post-surgery | |
Secondary | Change in Single Leg Squat (Maximum ROM until onset of pain) | single leg squat performance | baseline, 6 weeks and 1 year post-surgery | |
Secondary | Change in Bilateral Squat (Maximum ROM until onset of pain) | bilateral leg squat performance | baseline, 6 weeks and 1 year post-surgery | |
Secondary | Change in Tegner Activity Scale | Tegner Activity Scale | baseline, 6 weeks and 1 year post-surgery | |
Secondary | Change in Adverse events | any adverse events encountered | baseline, 2 weeks, 6 weeks and 1 year post-surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01623843 -
Femoroacetabular Impingement RandomiSed Controlled Trial
|
N/A | |
Completed |
NCT03669471 -
Muscular and Functional Performance in FAIS Patients
|
||
Not yet recruiting |
NCT05031390 -
the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
|
N/A | |
Active, not recruiting |
NCT05025956 -
Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02674113 -
Regional Anesthesia in Hip Arthroscopy
|
N/A | |
Withdrawn |
NCT02260726 -
Evaluation of Ultrasound for Detecting Hip Impingement
|
N/A | |
Recruiting |
NCT05391204 -
Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls
|
N/A | |
Active, not recruiting |
NCT03891563 -
Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
|
||
Active, not recruiting |
NCT04069507 -
Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
|
||
Terminated |
NCT03995290 -
3D Modeling to Improve Hip Arthroscopy Outcomes
|
||
Completed |
NCT06082271 -
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
|
N/A | |
Recruiting |
NCT01621360 -
Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement
|
N/A | |
Completed |
NCT04980209 -
The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
|
||
Enrolling by invitation |
NCT04988659 -
Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
|
||
Active, not recruiting |
NCT03494660 -
SCP Hip Outcomes Study
|
||
Active, not recruiting |
NCT04822571 -
Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
|
N/A | |
Withdrawn |
NCT02706756 -
Conservative Intervention of Femoroacetabular Impingement Syndrome
|
N/A | |
Completed |
NCT01993615 -
A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial
|
N/A | |
Completed |
NCT01814124 -
Conservative Management of Femoroacetabular Impingement
|
N/A | |
Completed |
NCT02702661 -
PRCT of FICB vs LAI for Hip Arthroscopy
|
N/A |