NCT03669471

Brief Summary

Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies. This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months. The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance. Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment. The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:

  1. 1.Hip muscle function
  2. 2.Single leg jump performance
  3. 3.Self-reported hip and groin function
  4. 4.Evaluation of return to sport
  5. 5.Evaluation of satisfaction regarding usual-care post-operative rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

September 7, 2018

Last Update Submit

December 15, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Peak force

    Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion

    Baseline (week 0)

  • Rate of force development

    0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion

    Baseline (week 0)

  • Self-reported hip and groin function (subjects included in prospective study)

    Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)

    Baseline (week 0) and follow-up (week 12)

Secondary Outcomes (7)

  • Single leg jump performance

    Baseline (week 0)

  • Self-reported hip and groin function

    Baseline (week 0)

  • Return to sport

    Baseline (week 0)

  • Satisfaction regarding usual-care post-operative rehabilitation

    Baseline (week 0)

  • Change in Peak force (subjects included in prospective study)

    Baseline (week 0) and follow-up (week 12)

  • +2 more secondary outcomes

Study Arms (1)

FAIS group

Subjects who have had a hip arthroscopy for femoroacetabular impingement during the preceding 6-30 months

Other: Testing of performance

Interventions

The cross-sectional evaluation will involve assessment of: 1. Hip muscle function 2. Single leg jump performance 3. Self-reported hip and groin function 4. Evaluation of return to sport 5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.

Also known as: Exercise-based treatment
FAIS group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome during the preceding 6-30 months in the Greater Copehangen Area

You may qualify if:

  • Male/female at the age of 18-40 years at the time of surgery
  • Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
  • Pre-operative cam morphology specified as an alpha angle ≥55°

You may not qualify if:

  • Pre-surgery joint space width \<3 mm
  • Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle \<25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Testing and exercise-based intervention will be conducted at Hvidovre Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lasse Ishøi

    Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 13, 2018

Study Start

September 13, 2018

Primary Completion

September 10, 2019

Study Completion

December 15, 2019

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations