Hip InjuriesFAINCT03959254
Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome
A study testing Physiotherapy post-surgical protocol for femoroacetabular impingement in people with Hip Injuries, run by Cardenal Herrera University at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Physiotherapy post-surgical protocol for femoroacetabular impingement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 19 Jun 2019to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Ceu Cardenal Herrera University
Moncada, Valencia, 46113
Universidad CEU Cardenal Herrera
Valencia, Moncada, 46113
About this study
Official title: EFFECTIVENESS OF A PROTOCOLIZED TREATMENT OF SPECIFIC PHYSIOTHERAPY FOR SUBJECTS SURGICALLY OPERATED BY ARTHROSCOPY FOR FEMOROACETABULAR SYNDROME
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.
- Conditions
- Hip Injuries
- Being tested
- Physiotherapy post-surgical protocol for femoroacetabular impingement
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy post-surgical protocol for femoroacetabular impingementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics. Receives: 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 Receives: Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Range of Mobility
The range of mobility is evaluated by goniometry.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start19 Jun 2019
- Primary completion19 Jun 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959254
- Sponsor's protocol ID
- CEU UCH FAI
- Acronym
- FAI
- Status last verified
- Dec 2019
- First submitted
- 16 May 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19089521Leunig 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.
PubMed 15043096Griffin 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.
PubMed 29893223Kuhns 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.
PubMed 28900574Wall 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.
PubMed 27629405Bennell 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.
PubMed 24571824Gocen 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.
PubMed 15180117Kemp 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.
PubMed 29607766
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A PROTOCOLIZED TREATMENT OF SPECIFIC PHYSIOTHERAPY FOR SUBJECTS SURGICALLY OPERATED BY ARTHROSCOPY FOR FEMOROACETABULAR SYNDROME
- ClinicalTrials.gov ID
- NCT03959254
- Acronym / sponsor ID
- FAI / CEU UCH FAI
- Conditions
- Hip Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingementApplication of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics. |
| Control Group | Active comparator | Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingementUsual post-surgical general guidelines for hip interventions described by Gocen et al |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy post-surgical protocol for femoroacetabular impingementThe 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. | Procedure or surgery | Control Group, Intervention Group |
Primary outcome
Hip Range of Mobility
Time frame: 14 weeks
The range of mobility is evaluated by goniometry.
Intensity of pain
Time frame: 14 weeks
The intensity of pain is evaluated by Visual Analogue Scale (VAS). The values are between 0 (absence of pain) to 10 (maximum intensity pain)
Functionality of the hip
Time frame: 14 weeks
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.
Fabere Test
Time frame: 14 weeks
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
Faddir Test
Time frame: 14 weeks
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
Ober test
Time frame: 14 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Background: PubMed 19089521Smith-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.
- Background: PubMed 15043096Leunig 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.
- Background: PubMed 29893223Griffin 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.
- Background: PubMed 28900574Kuhns 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.
- Background: PubMed 27629405Wall 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.
- Background: PubMed 24571824Bennell 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.
- Background: PubMed 15180117Gocen 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.
- Background: PubMed 29607766Kemp 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.
- The University CEU-Cardenal Herrera is the first private university in the Valencian Community. It belongs to the Foundation San Pablo CEU, the leading educational organization in Spain with three Universities all over Spain.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy post-surgical protocol for femoroacetabular impingement in people with Hip Injuries, run by Cardenal Herrera University at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Range of Mobility (time frame: 14 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959254, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.