NCT03959254

Brief Summary

Physiotherapy treatment protocols described in the bibliography after hip surgery are most of them nonspecific. An experimental study is proposed to determine the effectiveness of a protocolized treatment of physiotherapy in the postoperative treatment of femoroacetabular impingement treated by arthroscopy. This study tries to adapt the non-specific post-surgical physiotherapy treatment protocols of the hip to the characteristics of the femoroacetabular impingement and its arthroscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

May 16, 2019

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Hip Range of Mobility

    The range of mobility is evaluated by goniometry.

    14 weeks

  • Intensity of pain

    The intensity of pain is evaluated by Visual Analogue Scale (VAS). The values are between 0 (absence of pain) to 10 (maximum intensity pain)

    14 weeks

  • Functionality of the hip

    Modified Harris Hip Score Questionnaire (mHHS) is used to determine the functionality of the hip. The values are between 0 (lowest functionality) and 100 (normal function). The sub scales the subscales that compose it are hip pain (from 0 to 44), lameness in walking (from 0 to 11), need for walking aids (0 to 11), walked distance (0 to 11), ability to going up or down stairs (0 to 4), putting on shoes (0 to 4), sitting down without pain (0 to 5) and possibility of using public transport (0 to 1), with 0 being always the worst value.

    14 weeks

  • Fabere Test

    The patient's hip is flexed, abducted and externally rotated by placing the external malleolus on the knee of the contralateral leg. The pelvis is stabilized and an overpressure is applied to the inside of the knee. It is positive if the pain in the buttock or groin is reproduced. Test with inter-evaluator reliability in Kappa values (95% CI) of 0.60

    14 weeks

  • Faddir Test

    Flexion, adduction and internal rotation test. The supine patient, the evaluator patiently brings the patient's hip up to 100º flexion and adduction while applying internal rotation. It is positive if pain in the groin is reproduced. Test with inter-evaluator reliability in Kappa values of 0.48

    14 weeks

  • Ober test

    Patient in lateral decubitus position. The evaluator flexes the knee that is evaluated at 90º and abducts and extends the hip until it is level with the trunk. The evaluator lets the gravity bring the hip on aduction as possible. Test with inter-evaluator reliability of 0.90

    14 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics.

Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement

Control Group

ACTIVE COMPARATOR

Usual post-surgical general guidelines for hip interventions described by Gocen et al

Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement

Interventions

The intervention is structured in 14 weeks. Gradually the level of demand for the exercises increases over the weeks. Isometric and concentric exercises of the affected muscle groups are combined in the first weeks, as well as mobilization exercises of the joints involved in the injury. In addition, the time of permanence in a sitting, prone or supine position is prescribed. The return to the march and activities of daily life are staggered. The number of series and repetitions to be performed is described in each exercise.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having suffered hip / groin pain for at least 3 months.
  • Be a patient diagnosed with femoroacetabular syndrome by an orthopedic surgeon based on symptoms, clinical signs and diagnostic imaging.
  • To have signed the informed consent.
  • Have time available to follow a 14-week physiotherapy treatment program.
  • Be programmed for hip arthroscopy.
  • Be able to speak and understand the Spanish language.
  • Be between 18 and 50 years of age.

You may not qualify if:

  • To have received physiotherapy treatment in the last three months.
  • Having previously received hip surgery.
  • Subjects with previous deformities in the femur that severely alter joint mobility such as Perthes disease, gliding of the upper femoral epiphysis or avascular necrosis, acetabular fracture, hip dislocation or fracture of the femoral neck.
  • Evidence of preexisting osteoarthritis, defined as Tonnis grade\> 2
  • Subjects with previous deformities in the pelvis that severely alter joint mobility.
  • Any other cardiovascular, psychological and / or cognitive diagnosed pathology that impedes the correct understanding of the study and prevents objective study variables.
  • Subjects that are under the effects of anesthetics or muscle relaxants that mask the sensation of the patient before the techniques of the study.
  • Professional athletes.
  • Subjects in which hip arthroscopy is contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad CEU Cardenal Herrera

Valencia, Moncada, 46113, Spain

Location

Ceu Cardenal Herrera University

Moncada, Valencia, 46113, Spain

Location

Related Publications (8)

  • Smith-Petersen MN. The classic: Treatment of malum coxae senilis, old slipped upper femoral epiphysis, intrapelvic protrusion of the acetabulum, and coxa plana by means of acetabuloplasty. 1936. Clin Orthop Relat Res. 2009 Mar;467(3):608-15. doi: 10.1007/s11999-008-0670-0. Epub 2008 Dec 17.

    PMID: 19089521BACKGROUND
  • Leunig M, Podeszwa D, Beck M, Werlen S, Ganz R. Magnetic resonance arthrography of labral disorders in hips with dysplasia and impingement. Clin Orthop Relat Res. 2004 Jan;(418):74-80. doi: 10.1097/00003086-200401000-00013.

    PMID: 15043096BACKGROUND
  • Griffin DR, Dickenson EJ, Wall PDH, Achana F, Donovan JL, Griffin J, Hobson R, Hutchinson CE, Jepson M, Parsons NR, Petrou S, Realpe A, Smith J, Foster NE; FASHIoN Study Group. Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial. Lancet. 2018 Jun 2;391(10136):2225-2235. doi: 10.1016/S0140-6736(18)31202-9. Epub 2018 Jun 1.

    PMID: 29893223BACKGROUND
  • Kuhns BD, Weber AE, Batko B, Nho SJ, Stegemann C. A FOUR-PHASE PHYSICAL THERAPY REGIMEN FOR RETURNING ATHLETES TO SPORT FOLLOWING HIP ARTHROSCOPY FOR FEMOROACETABULAR IMPINGEMENT WITH ROUTINE CAPSULAR CLOSURE. Int J Sports Phys Ther. 2017 Aug;12(4):683-696.

    PMID: 28900574BACKGROUND
  • Wall PD, Dickenson EJ, Robinson D, Hughes I, Realpe A, Hobson R, Griffin DR, Foster NE. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial. Br J Sports Med. 2016 Oct;50(19):1217-23. doi: 10.1136/bjsports-2016-096368.

    PMID: 27629405BACKGROUND
  • Bennell KL, O'Donnell JM, Takla A, Spiers LN, Hunter DJ, Staples M, Hinman RS. Efficacy of a physiotherapy rehabilitation program for individuals undergoing arthroscopic management of femoroacetabular impingement - the FAIR trial: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Feb 26;15:58. doi: 10.1186/1471-2474-15-58.

    PMID: 24571824BACKGROUND
  • Gocen Z, Sen A, Unver B, Karatosun V, Gunal I. The effect of preoperative physiotherapy and education on the outcome of total hip replacement: a prospective randomized controlled trial. Clin Rehabil. 2004 Jun;18(4):353-8. doi: 10.1191/0269215504cr758oa.

    PMID: 15180117BACKGROUND
  • Kemp JL, Coburn SL, Jones DM, Crossley KM. The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial. J Orthop Sports Phys Ther. 2018 Apr;48(4):307-315. doi: 10.2519/jospt.2018.7941.

    PMID: 29607766BACKGROUND

Related Links

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 22, 2019

Study Start

June 19, 2019

Primary Completion

June 19, 2019

Study Completion

December 18, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations