Leg Length InequalityNCT03966573
Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints
A study testing Radiographic imaging, Evaluating function and Forms in people with Leg Length Inequality and Leg; Lengthening, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee
- What is being tested?
- Radiographic imaging, Evaluating function and Forms
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 6 Mar 2019to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.
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.
Read the detailed description
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.
- Conditions
- Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee, Osteoarthritis of Hip, Quality of Life
- Being tested
- Radiographic imaging, Evaluating function, Forms
- Medical subject headings
- Leg Length Inequality, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic imagingRadiation
Also called Knee front, knee side, lower extremity axis front, lower extremity axis side
Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.
Evaluating functionOther
Also called 30 seconds sit to stand, single leg hop test, stair test, goniometric ROM measurement hip and knee
Test function and physical capasity
FormsOther
Also called EQ-5D-5L, KOOS - knee osteoarthritis outcome score, IPAQ - international physical activity questionnaire
Forms for evaluating quality of life, pain, function
| Study group | Role | What they receive |
|---|---|---|
| Evaluating function, Radiographic imaging, Forms | Other | * Tests for lower extremity function
* Evaluating arthritis of hip and knee, leg length discrepancy and axis deviation radiographically
* Evaluating quality of life, function and pain by forms Receives: Radiation: Radiographic imaging; Other: Evaluating function; Other: Forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip or knee osteoarthritis
Radiographic imaging. Kellgren \& Lawrence classification and joint space width will be measured
Measured: One day
Lower extremity strength
30 seconds sit to stand test, measuring strength in lower extremities
Measured: one day
Lower extremity function
Single leg hop tests
Measured: one day
Aerob capasity
Stair test, 18 steps up and down three times
Measured: one day
measure of health related quality of life with EQ-5D-5L
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
Measured: one day
measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)
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
Measured: one day
measuring physical activity level with International Physical Activity Questionnaire (IPAQ)
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
Measured: one day
Active range of motion
Hand held goniometric measurement of active range of motion in hip and knee bilaterally
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start6 Mar 2019
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg Length InequalityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Responsible party
- Principal investigator, Patrick Aleksander Bjørge, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966573
- Sponsor's protocol ID
- 2018/416
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IDP that underlie results in a publication
Publications
Bjorge PA, Tveter AT, Steen H, Gunderson R, Horn J. Femoral lengthening might impair physical function and lead to structural changes in adjacent joints: 10 patients with 27 to 34 years' follow-up. Acta Orthop. 2021 Jun;92(3):329-334. doi: 10.1080/17453674.2020.1866864. Epub 2021 Jan 7.
PubMed 33410356
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.
- ClinicalTrials.gov ID
- NCT03966573
- Acronym / sponsor ID
- 2018/416
- Conditions
- Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee, Osteoarthritis of Hip, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluating function, Radiographic imaging, Forms | Other | Radiation: Radiographic imaging, Other: Evaluating function, Other: Forms* Tests for lower extremity function * Evaluating arthritis of hip and knee, leg length discrepancy and axis deviation radiographically * Evaluating quality of life, function and pain by forms |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic imagingAlso: Knee front, knee side, lower extremity axis front, lower extremity axis sideEvaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy. | Radiation | Evaluating function, Radiographic imaging, Forms |
| Evaluating functionAlso: 30 seconds sit to stand, single leg hop test, stair test, goniometric ROM measurement hip and kneeTest function and physical capasity | Other | Evaluating function, Radiographic imaging, Forms |
| FormsAlso: EQ-5D-5L, KOOS - knee osteoarthritis outcome score, IPAQ - international physical activity questionnaireForms for evaluating quality of life, pain, function | Other | Evaluating function, Radiographic imaging, Forms |
Primary outcome
hip or knee osteoarthritis
Time frame: One day
Radiographic imaging. Kellgren \& Lawrence classification and joint space width will be measured
Lower extremity strength
Time frame: one day
30 seconds sit to stand test, measuring strength in lower extremities
Lower extremity function
Time frame: one day
Single leg hop tests
Aerob capasity
Time frame: one day
Stair test, 18 steps up and down three times
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
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
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
Active range of motion
Time frame: one day
Hand held goniometric measurement of active range of motion in hip and knee bilaterally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Derived from this study: PubMed 33410356Bjorge PA, Tveter AT, Steen H, Gunderson R, Horn J. Femoral lengthening might impair physical function and lead to structural changes in adjacent joints: 10 patients with 27 to 34 years' follow-up. Acta Orthop. 2021 Jun;92(3):329-334. doi: 10.1080/17453674.2020.1866864. Epub 2021 Jan 7.
- Individual participant dataSharing planned: Yes. IDP that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiographic imaging, Evaluating function and Forms in people with Leg Length Inequality and Leg; Lengthening, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip or knee osteoarthritis (time frame: One day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.