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First-line Treatment for Femoroacetabular Impingement Syndrome (BetterHip)

Primary Purpose

Femoroacetabular Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Supervised strength exercise intervention
Minimal educational intervention (usual care)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement Syndrome focused on measuring Femoroacetabular Impingement Syndrome, FAI, Hip, Usual care, Exercise Therapy, Health economic evaluation, Effectiveness

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Activity- or position-related pain lasting ≥ 3 months Positive Flexion-Adduction-Internal rotation (FADIR) test Cam-type FAIS; x-ray alpha angle > 60 degrees OR crossover-sign Motivated to exercise 2 times a week for 6 months 18-50 years old Body Mass Index (BMI) score < 35 Exclusion Criteria: Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation). Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2 Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil). Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index > 10° Comorbidities or other problems considered to affect hip function and participation in exercise Unable to perform baseline testing procedures (1 RM unilateral leg press, One Leg Rise Test and Single Leg Hop for Distance) Unable to communicate in the respective languages of the participating countries

Sites / Locations

  • La Trobe University
  • Odense University HospitalRecruiting
  • Orthopaedic Center, Alborg sygehus, Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Horsens Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised strength exercise intervention

Usual care

Arm Description

Group 1

Group 2

Outcomes

Primary Outcome Measures

Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.
The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life.

Secondary Outcome Measures

Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.
Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine.
Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.
The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance.
Change in functional performance measured by the Single leg hop for distance test at end of intervention.
The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption.
Adherence to the 6 month to the supervised strength exercise intervention measured by a training diary and the Exercise Adherence Rating Scale (EARS).
The total score ranges from 0-24, higher scores indicating higher adherence.
The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)
Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well is evaluated using a single question. The scale is binary (yes/no).
Global Perceived Effect (GPE)
The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'Worse, an important worsening' (worst) to 'Better, an important improvement' (best)
AE (Adverse Events) & Serious Adverse Events (SAE)
Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 6- and 12-month follow-ups about potential AE and SAE using open-probe questions.
Drop-outs
Number of drop-out from the intervention groups.
Hip surgery
Number of hip surgeries within the follow-up period.
Exercise level
Exercise level (1-3), higher level indicating higher level of difficulty in exercises.
Number of sets
Number of sets (0-3), higher indicating completion of more sets in each exercise sessions. Number of sets will be used to calculate exercise dosage.
Number of repetitions
Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage.
External load
External load will be used to calculate exercise dosage.
Rate of perceived exertion
Rate of perceived exertion (0-10), higher scores indicating larger perceived effort.

Full Information

First Posted
May 31, 2023
Last Updated
August 10, 2023
Sponsor
University of Aarhus
Collaborators
Horsens Hospital, Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, La Trobe University
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1. Study Identification

Unique Protocol Identification Number
NCT05927935
Brief Title
First-line Treatment for Femoroacetabular Impingement Syndrome
Acronym
BetterHip
Official Title
First-line Treatment for Femoroacetabular Impingement Syndrome: a Multicenter Randomized Controlled Trial Comparing a Supervised Strength Exercise Intervention to Usual Care on Hip-related Quality of Life. (Better Hip Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Horsens Hospital, Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, La Trobe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise intervention to usual first-line care in patients with FAIS. The main hypothesis it aims to investigate are: 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.
Detailed Description
There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The Better Hip trial is a multicenter, stratified (by hospital site), randomized (allocation 1:1), controlled, assessor blinded, superiority trial conducted in Denmark (Aarhus, Horsens, Aalborg, and Odense) and Australia (Melbourne). Eligible patients will either be randomized to a supervised strength exercise intervention or to usual care. The primary outcome will be hip-related quality of life measured at end of intervention (6 months) with the iHOT-33. A health economic evaluation will assess the difference in cost-effectiveness between groups from baseline to 12 months. Secondary outcomes will be measured at baseline, 3-, 6- and 12- months after initiating the intervention for patient reported outcome measures (PROMs), and at baseline and 6-months for objective outcome measures obtained at clinical assessments. This trial aims to investigate the clinical and cost-effectiveness of a supervised strength exercise intervention compared to usual care as first-line treatment in patients with FAIS. A secondary aim is to explore how exercise adherence and dosage of a supervised strength exercise intervention mediates outcomes. The investigators hypothesis that; 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS. A full trial protocol will be published and made publicly available prior to analysis for the primary paper. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Supplementary to the intention-to-treat analysis a per protocol analysis will be conducted. Between-group differences will be analyzed using a linear mixed effect model for continuous outcomes and a logistical mixed effect model for binary outcome variables. Intervention group, recruitment site and time will be included as fixed effects and patients will be included as a random effect. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years for cost-utility and iHOT-33 for cost-effectiveness)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement Syndrome
Keywords
Femoroacetabular Impingement Syndrome, FAI, Hip, Usual care, Exercise Therapy, Health economic evaluation, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Masking is single-blinded to the outcome assessor, whom is unaware of the participant's treatment group. The outcome assessor is blinded to the allocation of the participant´s and participant's are asked not to disclose their allocation during test.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised strength exercise intervention
Arm Type
Experimental
Arm Description
Group 1
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Group 2
Intervention Type
Other
Intervention Name(s)
Supervised strength exercise intervention
Intervention Description
A 6 months exercise intervention of training 2 times a week. Patients will be instructed by a physiotherapist during the first session, in order to be able to perform the exercises at home or in a local gymnasium based on personal preference. Subsequently, there are supervised sessions once every second week (12 sessions in total). The intervention will consist of 6 exercises. 4 targeting planes of hip movement (i.e., flexion, extension, abduction and adduction), a general lower extremity- and a trunk exercise. Progression is made when an exercise is performed with the designated number of sets and repetitions, with good performance quality and tolerable pain. Progression is provided by 3 levels of difficulty and secondly by the number of repetitions or where possible by increasing the external load. In addition, patient information and education is identical to what is delivered in the usual care group.
Intervention Type
Other
Intervention Name(s)
Minimal educational intervention (usual care)
Intervention Description
Usual care varies slightly across regions in Denmark and between Denmark and Australia. The consensus is that the patient should be advised to remain physically active and reduce symptom provoking activities. Therefore, minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information in a leaflet on self-management of hip symptoms including advice about staying physically active in accordance with the World Health Organization guidelines on physical activity and sedentary behavior. Moreover, self-management of hip symptoms will include advice to reduce symptoms by focusing on symptom-lowering activities and sports. The content of the information provided as usual care will be identical to the information provided to the patients in the intervention group. Patients in the usual care group can continue to seek any additional treatment they would like and won't be prohibited from doing this.
Primary Outcome Measure Information:
Title
Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.
Description
The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life.
Time Frame
Measured at baseline, 3, 6 and 12 months.
Secondary Outcome Measure Information:
Title
Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.
Description
Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine.
Time Frame
Measured at baseline and 6 months.
Title
Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.
Description
The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance.
Time Frame
Measured at baseline and 6 months.
Title
Change in functional performance measured by the Single leg hop for distance test at end of intervention.
Description
The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption.
Time Frame
Measured at baseline and 6 months.
Title
Adherence to the 6 month to the supervised strength exercise intervention measured by a training diary and the Exercise Adherence Rating Scale (EARS).
Description
The total score ranges from 0-24, higher scores indicating higher adherence.
Time Frame
Registered throughout the 6 months intervention by patients and at 6 months follow-up using the Exercise Adherence Rating Scale (EARS).
Title
The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)
Description
Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well is evaluated using a single question. The scale is binary (yes/no).
Time Frame
Measured at baseline, 6 and 12 months.
Title
Global Perceived Effect (GPE)
Description
The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'Worse, an important worsening' (worst) to 'Better, an important improvement' (best)
Time Frame
Measured at 6 and 12 months.
Title
AE (Adverse Events) & Serious Adverse Events (SAE)
Description
Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 6- and 12-month follow-ups about potential AE and SAE using open-probe questions.
Time Frame
Registered throughout the 12-month study period.
Title
Drop-outs
Description
Number of drop-out from the intervention groups.
Time Frame
Registered throughout the 12-month study period.
Title
Hip surgery
Description
Number of hip surgeries within the follow-up period.
Time Frame
Measured at baseline, 3, 6 and 12 months.
Title
Exercise level
Description
Exercise level (1-3), higher level indicating higher level of difficulty in exercises.
Time Frame
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Title
Number of sets
Description
Number of sets (0-3), higher indicating completion of more sets in each exercise sessions. Number of sets will be used to calculate exercise dosage.
Time Frame
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Title
Number of repetitions
Description
Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage.
Time Frame
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Title
External load
Description
External load will be used to calculate exercise dosage.
Time Frame
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Title
Rate of perceived exertion
Description
Rate of perceived exertion (0-10), higher scores indicating larger perceived effort.
Time Frame
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Other Pre-specified Outcome Measures:
Title
Change in health outcome measured by the EuroQol Group 5-dimension 5 Level (EQ-5D-5L).
Description
The EQ-5D-5L is a five-item patient-reported outcome measure designed to assess generic health-related quality-of-life. The total score of the descriptive index and EQ-VAS ranges from -0.624 (worst) to 1.000 (best).
Time Frame
Measured at baseline, 3, 6 and 12 months.
Title
Change in health outcome measured by the EuroQol Group VAS (EQ-VAS)
Description
The EQ-VAS is a patient-reported outcome measure designed to assess generic health-related quality-of-life. The total score ranges and 0 (worst imaginable health) to 100 (best imaginable health).
Time Frame
Measured at baseline, 3, 6 and 12 months.
Title
Productivity losses measured by the Productivity Costs Questionnaire (IPCQ)
Description
The IPCQ questionnaire includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work.
Time Frame
Measured at baseline, 3, 6 and 12 months.
Title
Healthcare and medicine usage measured by the Healthcare Utilization Questionnaire (HUQ)
Description
The HUQ is a nine-item patient-reported outcome measure designed to assess healthcare and medicine usage.
Time Frame
Measured at baseline, 3, 6 and 12 months.
Title
Pain catastrophizing measured by the Tampa Scale of Kinesiophobia 17 items (TSK-17).
Description
The Tampa Scale of Kinesiophobia (TSK) is a valid and reliable tool to assess somatic focus and activity avoidance in patients. TSK-17 consists of 17 statements which measure pain-related fear of movement in patients with chronic musculoskeletal pain. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
Measured at baseline, 6 and 12 months.
Title
Change in pain measured by the The Copenhagen Hip and Groin Outcome Score (HAGOS) Pain subscale.
Description
The HAGOS pain subscale is a ten-item patient-reported outcome measure designed to assess pain in physically active, young to middle-aged patients with longstanding hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better symptom status.
Time Frame
Measured at baseline and 6 months.
Title
Change Quality of Life measured by the HAGOS Quality of Life subscale.
Description
The HAGOS Physical function in Quality of Life subscale is a five-item patient-reported outcome measure designed to assess quality of life in physically active, young to middle-aged patients with longstanding hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better symptom status.
Time Frame
Measured at baseline and 6 months.
Title
Change in physical function measured by the HAGOS Physical function in Sport and Recreation subscale
Description
The HAGOS Physical function in Sport and Recreation subscale is an eight-item patient-reported outcome measure designed to assess physical function in sport and recreation in physically active, young to middle-aged patients with longstanding hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better symptom status.
Time Frame
Measured at baseline and 6 months.
Title
Physical activity measured by The short questionnaire to assess health-enhancing physical activity (SQUASH).
Description
The short questionnaire to assess health-enhancing physical activity (SQUASH). calculates the total activity score as the sum of activity scores (i.e., category: commuting activities, activities at work or school, household activities and leisure-time and sports activities multiplied by intensity score. The total activity score is calculated as the sum of the activity scores for each activity, higher scores indicating more physical activity).
Time Frame
Measured at baseline, 6 and 12 months.
Title
Sports participation measured by The Hip Sports Activity Scale (HSAS).
Description
The HSAS is a reliable and valid tool to determine sports levels in patients suffering from FAIS. The HSAS is a 9-level scale ranging from 0 to 8, where 8 represents competitive sport at the elite level.
Time Frame
Measured at baseline, 6 and 12 months.
Title
Sports participation measured by Return to Sport (RTS) question.
Description
A consensus statement on RTS stated that RTS should be reported on a continuum from return to participation through return to sport and, finally, return to performance.
Time Frame
Measured at 6 and 12 months.
Title
Change in symptoms measured by the International Hip and Outcome Tool 33 (iHOT-33) Symptoms subscale.
Description
The iHOT-33 subscale Symptoms is an sixteen-item patient-reported outcome measure designed to assess symptoms in patients hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better status.
Time Frame
Measured at baseline 3, 6 and 12 months.
Title
Change in sport and recreational activities measured by the International Hip and Outcome Tool 33 (iHOT-33) Sports and Recreational activities subscale.
Description
The iHOT-33 subscale Sports and Recreational activities is a six-item patient-reported outcome measure designed to assess sport and recreational activities in patients hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better status.
Time Frame
Measured at baseline 3, 6 and 12 months.
Title
Change in job related concerns measured by the International Hip and Outcome Tool 33 (iHOT-33) Job related concerns subscale.
Description
The iHOT-33 subscale Job related concerns activities is a four-item patient-reported outcome measure designed to assess job related concerns in patients hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better status.
Time Frame
Measured at baseline 3, 6 and 12 months.
Title
Change in social, emotional and lifestyle concerns measured by the International Hip and Outcome Tool 33 (iHOT-33) Social, Emotional and Lifestyle concerns subscale.
Description
The iHOT-33 subscale Social, Emotional and Lifestyle concerns is a seven-item patient-reported outcome measure designed to assess social, emotional and lifestyle concerns in patients hip and/or groin pain. The total score ranges from 0 to 100, with higher scores indicating better status.
Time Frame
Measured at baseline 3, 6 and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Activity- or position-related pain lasting ≥ 3 months Positive Flexion-Adduction-Internal rotation (FADIR) test Cam-type FAIS; x-ray alpha angle > 60 degrees OR crossover-sign Motivated to exercise 2 times a week for 6 months 18-50 years old Body Mass Index (BMI) score < 35 Exclusion Criteria: Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation). Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2 Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil). Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index > 10° Comorbidities or other problems considered to affect hip function and participation in exercise Unable to perform baseline testing procedures (1 RM unilateral leg press, One Leg Rise Test and Single Leg Hop for Distance) Unable to communicate in the respective languages of the participating countries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederik Foldager, MSc
Phone
+4522782041
Email
frederikfoldager@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Inger Mechlenburg, Prof.
Phone
+4521679062
Email
inger.mechlenburg@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Foldager, MSc
Organizational Affiliation
Aarhus University Hospital and Aarhus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg, Prof.
Organizational Affiliation
Aarhus University Hospital and Aarhus University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Signe Kierkegaard-Brøchner, Postdoc
Organizational Affiliation
Horsens Regional Hospital and Aarhus University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanne Kemp, Ass. Prof.
Organizational Affiliation
Latrobe Sports Exercise Medicine Research Centre, School of Allied Health, La Trobe University
Official's Role
Study Director
Facility Information:
Facility Name
La Trobe University
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Kemp, Ass. Prof.
Email
J.Kemp@latrobe.edu.au
Facility Name
Odense University Hospital
City
Odense
State/Province
Region Of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Holsgaard Larsen
Email
ahlarsen@health.sdu.dk
Facility Name
Orthopaedic Center, Alborg sygehus, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsen Møller Poulsen Mølgaard
Email
cmm@rn.dk
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg, PhD
Email
inger.mechlenburg@au.dk
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg, PhD
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Kierkegaard, MSc
Phone
0045 2490 1231
Email
signkier@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
IPD Sharing Time Frame
Data will be available after publication of the trial.
IPD Sharing Access Criteria
Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.

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First-line Treatment for Femoroacetabular Impingement Syndrome

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