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NCT Number: NCT03966573

Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints

This study evaluates function, quality of life and development of hip- and knee osteoarthritis minimum 15 years after unilateral femoral lengthening on people with idiopathic or post-traumatic anisomelia.

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Key information

Conditions

Leg Length Inequality Arthritis Bone Diseases Bone Diseases, Developmental Joint Diseases Leg; Lengthening Musculoskeletal Diseases Osteoarthritis Osteoarthritis of Hip Osteoarthritis, Hip Osteoarthritis, Knee Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Quality of Life Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0372, Norway

About this study

This study has a cross-sectional design, where patients that completed femoral lengthening more than 15 years ago and fulfills the inclusion criteria's are invited to participate. Patients will undergo radiographic imaging to evaluate hip- and knee arthritis, axis deviaton and leg length discrepancy. To evaluate quality of life, function and pain, the participants will complete the forms EQ-5D-5L, Knee osteoarthritis outcome score (KOOS) and International physical activity questionnaire (IPAQ). Bilateral active hip and knee range of motion will be measured with hand held goniometer, and the functional tests 30 seconds sit to stand, hop tests and stair test will be conducted.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

Exclusion criteria

  • Patients that are lenghtened with innate pathology resulting in shortening of the limb, angle deviation and less musculature, for example congenital femoral deficiency or fibula hemimelia.
  • Patients with acquired leg length discrepancy who have had infection in knee or hip joint

Treatment and study plan

Radiographic imaging

Radiation

Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.

Other names: Knee front, knee side, lower extremity axis front, lower extremity axis side, pelvis front

Evaluating function

Other

Test function and physical capasity

Other names: 30 seconds sit to stand, single leg hop test, stair test, goniometric ROM measurement hip and knee

Forms

Other

Forms for evaluating quality of life, pain, function

Other names: EQ-5D-5L, KOOS - knee osteoarthritis outcome score, IPAQ - international physical activity questionnaire

Primary outcomes

  1. hip or knee osteoarthritis

    Time frame: One day

    Radiographic imaging. Kellgren & Lawrence classification and joint space width will be measured

  2. Lower extremity strength

    Time frame: one day

    30 seconds sit to stand test, measuring strength in lower extremities

  3. Lower extremity function

    Time frame: one day

    Single leg hop tests

  4. Aerob capasity

    Time frame: one day

    Stair test, 18 steps up and down three times

  5. measure of health related quality of life with EQ-5D-5L

    Time frame: one day

    participants report the extent of problems they have with endpoints 1-5, where 1 is no problems and 5 is not able to in the five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The questionnaire also contains a vertical analogue scale with the labelled endpoints 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state, giving a valuation of the participants own health state that can be used as a quantitative measure of health outcome based on the patients' own judgement

  6. measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)

    Time frame: one day

    The participant answer questions regarding pain, function, stiffness and quality of life regarding knee pain. Endpoints 0 - 4, where 0 indicate no problems and 4 indicate extreme problems

  7. measuring physical activity level with International Physical Activity Questionnaire (IPAQ)

    Time frame: one day

    Participants answer the amount of time being in vigorous activity, moderate activity, walking and sitting during the last 7 days. Answers are given in number of days in each of the activity categories, and time in hours and minutes on a regular day the actual week

  8. Active range of motion

    Time frame: one day

    Hand held goniometric measurement of active range of motion in hip and knee bilaterally

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sophies Minde Ortopedi

Registry information

Official study title

Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2019
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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