Targeted Exercise and Changes in Femoroacetabular Impingement in Symptomatic Patients With Acetabular Retroversion

NCT03578562 | Completed DMC

• 1 other identifier: 1- Brekke
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effectiveness of an 8-week home-based targeted training intervention aiming at reducing FAI related pain, anterior pelvic tilt and improve hip joint function in a cohort of 40 patients (18 to 40 years), with acetabular retroversion and anterior pelvic tilt not eligible for surgery (Ganz osteotomy) from the hospital outpatient clinic.

Conditions

Acetabular Dysplasia

Keywords

Femoroacetabular Impingement; Anterior Pelvic Tilt

Outcome Measures

Primary Outcomes (1)

• HAGOS questionnaire (pain subscale)

  Change in The Copenhagen Hip and Groin Outcome Score (HAGOS) questionnaire pain subscale. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4, where 0 indicates no problem. The scores from each subscale are calculated as the sum of the items included. Raw scores are then transformed to a 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems.

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

Secondary Outcomes (3)

• HAGOS questionnaire (the remaining five subscales)

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

• EQ-5D-3Levels questionnaire

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline).

• Radiographic measurement of pelvic tilt (SCJ - Symphysis distance)

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

Other Outcomes (28)

• Global Perceived Effect anchor-question

  8-weeks (post-intervention) and 26 weeks (follow up from baseline)

• Oxford 12-item Hip Score (OHS) questionnaire, Danish version

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

• UCLA activity scale

  Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline).

Study Arms (1)

Targeted training intervention

EXPERIMENTAL

An 8-week progressive homebased training intervention with supervised booster-sessions

Other: Targeted training intervention

Interventions

Targeted training intervention OTHER

An 8-week progressive homebased training intervention with supervised booster-sessions

Targeted training intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed from a standard standing anterior-posterior pelvic radiograph with acetabular retroversion due to cross-over-sign and posterior-wall-sign
• Not eligible for Ganz osteotomy
• Ability to take part in the intervention

You may not qualify if:

• Having a Pelvic Tilt Ratio greater than 0.5, (the height of the obturator foramen divided by the height of the lesser pelvis) indicating posterior pelvic tilt, assessed from a standard standing AP-pelvic radiograph
• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• University College Absalon. Region of Zealand, Denmark: collaborator
• The Danish Rheumatism Association: collaborator
• Vanfoerefonden, Denmark: collaborator

Study Sites (1)

University of Southern Denmark - Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (11)

• 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.

  PMID: 10204935 BACKGROUND

• 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.

  PMID: 16452750 BACKGROUND

• 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.

  PMID: 19205323 BACKGROUND

• 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.

  PMID: 17137820 BACKGROUND

• 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.

  PMID: 21709030 BACKGROUND

• 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.

  PMID: 23669751 BACKGROUND

• 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.

  PMID: 14646708 BACKGROUND

• 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.

  PMID: 25060073 BACKGROUND

• 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.

  PMID: 28373141 BACKGROUND

• 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.

  PMID: 3383491 BACKGROUND

• 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.

  PMID: 29651575 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation; Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders F Brekke, PT, MSc

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: July 6, 2018
• Study Start: November 8, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion February 2020 all data will be anonymized and stored in a secure Sharepoint folder indefinitely.
• Access Criteria: The Sharepoint folder is hosted by Odense University Hospital, Region Southern Denmark. Only employees from the Orthopaedic Research unit at Odense University Hospital can access the folder using individual log in codes.

Locations

DK (1)