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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453592
Other study ID # ALTBKFO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 22, 2019
Est. completion date January 18, 2021

Study information

Verified date August 2021
Source Aspetar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Adductor-related groin pain is the most common type of groin pain in athletes, and pain at the proximal adductor longus insertion is a key finding in the diagnosis of longstanding groin pain. "Tightness" or "shortening" of the adductor longus is considered both a cause and effect of pain, that can lead to increased tension at the proximal insertion, thus playing a role in the persistence of longstanding adductor-related pain. For patients who do not respond sufficiently to non-surgical procedures, an adductor longus tenotomy is a surgical option that is considered to reduce tension at the proximal adductor longus insertion assisting in reduction of pain and return to sport. The bent knee fall out test (BKFO) is one of the most commonly used tests to test adductor flexibility. This test involves a combined hip movement with hip flexion, abduction, and external rotation, and a high result is generally considered to be related to adductor muscle "tightness", specifically that of the adductor longus. It is uncertain whether the BKFO test is actually measuring adductor muscle flexibility or hip joint range of motion, as the test results may also be affected by a femoral head cam morphology. A slightly different test, called the Patrick FABER's test, involves a similar movement and is mainly used as a hip joint pain provocation test. By cutting the adductor longus tendon, thereby removing the effect of potential adductor longus "tightness", it will be possible to show if and how much the flexibility of this muscle affects the BKFO test results. This will assist in future considerations of what this test is actually testing. The aim of this study is to investigate the immediate effect of an adductor longus tenotomy on the results of the bent knee fall out test.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 18, 2021
Est. primary completion date May 22, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - No specific exclusion criteria were present other than refusal to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention assigned as part of this study.
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.

Locations

Country Name City State
France Clinique du sport Bordeaux - Mérignac Merignac

Sponsors (2)

Lead Sponsor Collaborator
Aspetar Clinique du sport

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
See also
  Status Clinical Trial Phase
Completed NCT03590145 - Reliability of the Doha Agreement Classification of Groin Pain