Targeted Exercise and Changes in Femoroacetabular Impingement in Symptomatic Patients With Acetabular Retroversion
NCT ID: NCT03578562
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2018-11-08
2019-12-17
Brief Summary
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Detailed Description
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A prospective cohort study of 40 patients will undergo an 8-week targeted exercise intervention executed as progressive home-based training with supervised booster-sessions. Patients (18 to 40 years) with acetabular retroversion and anterior pelvic tilt not eligible for surgery (Ganz osteotomy) will be recruited from the outpatient clinic.
Time points for testing are at 1) minus 8-weeks (beginning of control-period) 2) baseline (beginning of training period) 3) plus 8-weeks (end of training period) and 4) plus 26 weeks from baseline (follow up).
The primary outcome measure is self-perceived level of hip related pain (HAGOS questionnaire subscale). Secondary outcome measures are self-perceived level of function and quality of life (remaining HAGOS-subscales), EQ-5D-3Levels questionnaire and radiographic degree of pelvic tilt in standing posture (EOS-scanning). Explorative outcome measures include additional radiographic measurements, patient-reported outcome measurements (PROM´s), functional testing and physical performance. The primary endpoint for assessing the outcome of the intervention will be 8 weeks after start of intervention. At 26-week follow up, only the PROM´s will be applied. All participants must fill in a mandatory exercise related dairy concerning adherence, level of pain and potential adverse events.
The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark, Project ID: S-20160072 Forty participants in total will be enrolled from the hip outpatient clinic at Odense University Hospital, Denmark. Paired means sample size calculation = 36 (10 % pre-posttest difference on HAGOS pain-subscale, SD=20.6, alpha = 0.05, power = 80 %), plus 10 % dropout = 4.
A list generated of 20 randomly found numbers from 1-40 will be used to select participants to be investigated in the motion laboratory. The number on the list corresponds to the order the participants are recruited into the study. In the motion laboratory, the explorative outcomes Functional testing (3D motion capture) and Physical performance (isometric muscle strength, joint range-of-motion, and single-leg hop for distance) will be tested.
To our knowledge, this is the first study investigating a targeted training intervention aiming at reducing FAI related pain, anterior pelvic tilt and improve hip joint function in patients with acetabular retroversion. Consequently, the study will provide knowledge that may help to develop non-surgical treatment strategies for this group of patients.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Targeted training intervention
An 8-week progressive homebased training intervention with supervised booster-sessions
Targeted training intervention
An 8-week progressive homebased training intervention with supervised booster-sessions
Interventions
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Targeted training intervention
An 8-week progressive homebased training intervention with supervised booster-sessions
Eligibility Criteria
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Inclusion Criteria
* Not eligible for Ganz osteotomy
* Ability to take part in the intervention
Exclusion Criteria
* Radiographic sign of hip osteoarthritis (\< 2mm. joint space),
* Previous lumbar, pelvic or hip related operations
* Conditions not allowing exercise therapy
* Body mass index (BMI) above 35
* Not understanding spoken and/or written Danish language
18 Years
40 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
University College Absalon. Region of Zealand, Denmark
UNKNOWN
The Danish Rheumatism Association
OTHER
Vanfoerefonden, Denmark
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Anders F Brekke, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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University of Southern Denmark - Odense University Hospital
Odense C, , Denmark
Countries
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References
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Reynolds D, Lucas J, Klaue K. Retroversion of the acetabulum. A cause of hip pain. J Bone Joint Surg Br. 1999 Mar;81(2):281-8. doi: 10.1302/0301-620x.81b2.8291.
Ezoe M, Naito M, Inoue T. The prevalence of acetabular retroversion among various disorders of the hip. J Bone Joint Surg Am. 2006 Feb;88(2):372-9. doi: 10.2106/JBJS.D.02385.
Werner CM, Copeland CE, Ruckstuhl T, Stromberg J, Seifert B, Turen CH. Prevalence of acetabular dome retroversion in a mixed race adult trauma patient population. Acta Orthop Belg. 2008 Dec;74(6):766-72.
Langlais F, Lambotte JC, Lannou R, Gedouin JE, Belot N, Thomazeau H, Frieh JM, Gouin F, Hulet C, Marin F, Migaud H, Sadri H, Vielpeau C, Richter D. Hip pain from impingement and dysplasia in patients aged 20-50 years. Workup and role for reconstruction. Joint Bone Spine. 2006 Dec;73(6):614-23. doi: 10.1016/j.jbspin.2006.09.001. Epub 2006 Oct 25.
Rylander JH, Shu B, Andriacchi TP, Safran MR. Preoperative and postoperative sagittal plane hip kinematics in patients with femoroacetabular impingement during level walking. Am J Sports Med. 2011 Jul;39 Suppl:36S-42S. doi: 10.1177/0363546511413993.
Clohisy JC, Baca G, Beaule PE, Kim YJ, Larson CM, Millis MB, Podeszwa DA, Schoenecker PL, Sierra RJ, Sink EL, Sucato DJ, Trousdale RT, Zaltz I; ANCHOR Study Group. Descriptive epidemiology of femoroacetabular impingement: a North American cohort of patients undergoing surgery. Am J Sports Med. 2013 Jun;41(6):1348-56. doi: 10.1177/0363546513488861. Epub 2013 May 13.
Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.
Ross JR, Nepple JJ, Philippon MJ, Kelly BT, Larson CM, Bedi A. Effect of changes in pelvic tilt on range of motion to impingement and radiographic parameters of acetabular morphologic characteristics. Am J Sports Med. 2014 Oct;42(10):2402-9. doi: 10.1177/0363546514541229. Epub 2014 Jul 24.
Riviere C, Hardijzer A, Lazennec JY, Beaule P, Muirhead-Allwood S, Cobb J. Spine-hip relations add understandings to the pathophysiology of femoro-acetabular impingement: A systematic review. Orthop Traumatol Surg Res. 2017 Jun;103(4):549-557. doi: 10.1016/j.otsr.2017.03.010. Epub 2017 Apr 1.
Ganz R, Klaue K, Vinh TS, Mast JW. A new periacetabular osteotomy for the treatment of hip dysplasias. Technique and preliminary results. Clin Orthop Relat Res. 1988 Jul;(232):26-36.
Schwarz T, Benditz A, Springorum HR, Matussek J, Heers G, Weber M, Renkawitz T, Grifka J, Craiovan B. Assessment of pelvic tilt in anteroposterior radiographs by means of tilt ratios. Arch Orthop Trauma Surg. 2018 Aug;138(8):1045-1052. doi: 10.1007/s00402-018-2931-z. Epub 2018 Apr 12.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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1- Brekke
Identifier Type: -
Identifier Source: org_study_id