NCT04453592

Brief Summary

The bent knee fall out test (BKFO) is a common test for hip adductor flexibility. It is unknown whether the BKFO actually tests the the adductors or potentially hip range of motion instead. In this study, the BKFO test is performed in the operating theater before and after an adductor longus tenotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

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

Study Start

First participant enrolled

November 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

June 22, 2020

Results QC Date

August 8, 2023

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the Bent Knee Fall Out Test

    The patient lies supine on the surgical table with app. 90° knee flexion, 45° hip flexion, and the feet together and the hips in external rotation (also known as the frog-leg position. Standardization of position is achieved by flexing one leg first, so the medial malleolus is placed next to the medial knee joint line of the contra-lateral leg. The knee is then moved laterally, externally rotating the hip with the plantar surface placed towards the contra-lateral leg. The contra-lateral leg is then flexed, and the plantar surfaces of the feet are aligned. The distance between the most distal point on the head of the fibula and the surface of the surgical table is measured using a rigid tape measure and distance is recorded in cm to the nearest 0.5 cm

    Baseline pre-surgery and immediately after the surgery.

Interventions

The intervention included in this study is part of routine medical care, and not assigned as a result of study participation. This study includes only the addition of a measurement; the bent knee fall out test. Therefore, we believe this study design is observational, and in line with the provided observation study design definition: "Observational: studies in human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention." See uploaded study protocol for further details.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Athletes with groin pain are consecutively recruited from two clinics of a visceral surgeon specialized in groin pain in athletes. The clinics are located in Bordeaux and Paris, France, and patient population includes athletes from all over France.

You may qualify if:

  • adults (\>18 years old)
  • athletes (recreational or elite)
  • clinical diagnosis of adductor-related groin pain
  • patients undergoing unilateral or bilateral adductor longus tenotomy by one general surgeon.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du sport Bordeaux - Mérignac

Mérignac, 33700, France

Location

Results Point of Contact

Title
Dr Andreas Serner
Organization
FIFA

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 1, 2020

Study Start

November 22, 2019

Primary Completion

May 22, 2020

Study Completion

January 18, 2021

Last Updated

March 3, 2025

Results First Posted

March 3, 2025

Record last verified: 2025-02

Locations