Knee OsteoarthritisSHIELDNCT03473873
Protective Role of Muscle Function for Early Features of Knee Osteoarthritis After Anterior Cruciate Ligament Injury
An observational study of Knee Osteoarthritis and Anterior Cruciate Ligament Injury, run by Lund University at 2 sites in 2 countries.
Trial summary
In this longitudinal prospective cohort study including young people with anterior cruciate ligament reconstruction (ACLR), the aims are to 1) study the association between different measures of muscle function and early future of knee osteoarthritis (OA) assessed as patient-reported pain, 2) explore potential… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Knee Osteoarthritis, Anterior Cruciate Ligament Injury, Osteoarthritis, Knee
- What is being tested?
- Measures of muscle function
- How many people
- 106 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Mar 2018to 1 Jul 2023
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited from the Department of Orthopedics, Skåne University Hospital, Sweden and the Department of Orthopedics, Ullevål Hospital, Oslo, Norway. The majority of patients (approx. 80%) will be included in Sweden. Non-injured controls will be recruited among students at Lund University, Lund, Sweden.
Who may be able to join
- One year after ACL reconstruction (ACLR)
- With or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury)
- Age 18-35 years
- Age 18-35 years
- No previous injuriy or surgery to either knee
Who cannot join
- Less than 10 months after ACLR
- More than 16 months after ACLR
- Injury or surgery to other knee (e.g., ACL, meniscal)
- Previous knee surgery index knee
- Previous serious knee injury index knee resulting in pain, swelling, and/or requiring inpatient or outpatient health care (e.g., ACLR, meniscus, patella luxation)
- Diseases or disorders overriding the knee condition (e.g., neurological disease)
- Contraindications for MRI
- Not understanding the languages of interest (any Scandinavian language or English)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Is Good Muscle Function a Protective Factor for Early Features of Knee Osteoarthritis After Anterior Cruciate Ligament Injury (SHIELD)? A Prospective Cohort Study
In this longitudinal prospective cohort study including young people with anterior cruciate ligament reconstruction (ACLR), the aims are to 1) study the association between different measures of muscle function and early future of knee osteoarthritis (OA) assessed as patient-reported pain, 2) explore potential associations between muscle function and features indicative of early radiographic OA measured with MRI, and early detection of OA in biomarker profiles, respectively, 3) monitor the patients' functional status, and early OA development over time and 4) investigate the prevalence of early knee OA in individuals 1 and 3 years post ACLR, respectively, compared to non-injured controls.The main hypothesis is that knee extensor weakness predicts future symptomatic OA of the knee (KOOS pain).
Read the detailed description
This is a longitudinal, prospective, cohort study. The reporting will adhere to the STROBE guidelines. Approximately 100 patients 12 months (range 10 - 16 months) after anterior cruciate ligament reconstruction (ACLR) will be recruited from Skåne University Hospital, Sweden and Ullevål Hospital, Oslo, Norway. The majority of the patients (approx. 80 %) will be recruited in Sweden. As a sample of convenience, 20 age- and sex-matched non-knee injured individuals will be recruited among students in Lund, Sweden.
A research coordinator at each site will determine eligibility for the study, based on pre-specified inclusion and exclusion criteria. Patients will be provided with written and oral information about the study. Patients who accept to participate will be assessed with various measures of muscle function, patient-reported outcomes, MRI, and blood samples for biomarker analyses, at baseline (1 year after ACLR) and 2 years later (3 years after ACLR).
For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression model will be used to elucidate the influence of change in each muscle function variable on change in primary, secondary and exploratory outcomes (biomarkers), adjusted for baseline values. Separate linear regression models will also be used to elucidate the influence of demographic factors on change in muscle function, self-reported outcomes, and early OA. Assuming a clinically relevant correlation of 0.30 between knee extension strength and self-reported pain, 84 patients are needed with 80% power at the 5% significance level. Based on this calculation, 100 patients will be included, including an approximate drop-out of 15%. For explorative purposes, an analysis of covariance (ANCOVA) will be used to investigate differences in the presence of early knee OA between the 100 patients with ACLR and twenty sex and age matched non-injured individuals, adjusting for activity level.
- Conditions
- Knee Osteoarthritis, Anterior Cruciate Ligament Injury, Osteoarthritis, Knee, Muscle Weakness
- Being tested
- Measures of muscle function
- Medical subject headings
- Osteoarthritis, Knee, Anterior Cruciate Ligament Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of muscle functionOther
The participants will be assessed with various measures of muscle function at baseline and at follow up including: Isokinetic knee muscle strength, Isometric strength of trunk and lower extremity, single-leg hop for distance (SLHD), side hop, postural orientation errors (single leg-squat, stair descending, forward lunge, SLHD), hip and ankle range of motion, and muscular activation patterns.
| Study group | Role | What they receive |
|---|---|---|
| SHIELD | Patients with anterior cruciate ligament injury Receives: Other: Measures of muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported pain
Knee Osteoarthritis Outcome Score (KOOS) subscale pain
Measured: Change from baseline to 2-year follow up
Secondary outcomes (1)
Compositional MRI (T2 relaxation time and 3DPD)
Compositional MRI, a proxy for early morphological degeneration of joint structures. Quantitative morphology of cartilage quality will be made using T2 mapping, to measure collagen orientation changes within the cartilage, and bone shape (3DPD)
Measured: Change from baseline to 2-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start9 Mar 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PhD, Principal investigator, Department of Health Sciences, Lund University, PO Box 157, 221 00 Lund, SwedenMay Arna Risberg, PhD, Principal investigator, Oslo University Hospital, Division of Orthopedic Surgery, PO.Box 4956 Nydalen, 0424 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473873
- Sponsor's protocol ID
- 2016/319
- Acronym
- SHIELD
- Status last verified
- Oct 2023
- First submitted
- 9 Mar 2018
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Good Muscle Function a Protective Factor for Early Features of Knee Osteoarthritis After Anterior Cruciate Ligament Injury (SHIELD)? A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03473873
- Acronym / sponsor ID
- SHIELD / 2016/319
- Conditions
- Knee Osteoarthritis, Anterior Cruciate Ligament Injury, Osteoarthritis, Knee, Muscle Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Mar 2018 (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.
In this longitudinal prospective cohort study including young people with anterior cruciate ligament reconstruction (ACLR), the aims are to 1) study the association between different measures of muscle function and early future of knee osteoarthritis (OA) assessed as patient-reported pain, 2) explore potential associations between muscle function and features indicative of early radiographic OA measured with MRI, and early detection of OA in biomarker profiles, respectively, 3) monitor the patients' functional status, and early OA development over time and 4) investigate the prevalence of early knee OA in individuals 1 and 3 years post ACLR, respectively, compared to non-injured controls.The main hypothesis is that knee extensor weakness predicts future symptomatic OA of the knee (KOOS pain).
Detailed description
This is a longitudinal, prospective, cohort study. The reporting will adhere to the STROBE guidelines. Approximately 100 patients 12 months (range 10 - 16 months) after anterior cruciate ligament reconstruction (ACLR) will be recruited from Skåne University Hospital, Sweden and Ullevål Hospital, Oslo, Norway. The majority of the patients (approx. 80 %) will be recruited in Sweden. As a sample of convenience, 20 age- and sex-matched non-knee injured individuals will be recruited among students in Lund, Sweden.
A research coordinator at each site will determine eligibility for the study, based on pre-specified inclusion and exclusion criteria. Patients will be provided with written and oral information about the study. Patients who accept to participate will be assessed with various measures of muscle function, patient-reported outcomes, MRI, and blood samples for biomarker analyses, at baseline (1 year after ACLR) and 2 years later (3 years after ACLR).
For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression model will be used to elucidate the influence of change in each muscle function variable on change in primary, secondary and exploratory outcomes (biomarkers), adjusted for baseline values. Separate linear regression models will also be used to elucidate the influence of demographic factors on change in muscle function, self-reported outcomes, and early OA. Assuming a clinically relevant correlation of 0.30 between knee extension strength and self-reported pain, 84 patients are needed with 80% power at the 5% significance level. Based on this calculation, 100 patients will be included, including an approximate drop-out of 15%. For explorative purposes, an analysis of covariance (ANCOVA) will be used to investigate differences in the presence of early knee OA between the 100 patients with ACLR and twenty sex and age matched non-injured individuals, adjusting for activity level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHIELD | – | Other: Measures of muscle functionPatients with anterior cruciate ligament injury |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the Department of Orthopedics, Skåne University Hospital, Sweden and the Department of Orthopedics, Ullevål Hospital, Oslo, Norway. The majority of patients (approx. 80%) will be included in Sweden. Non-injured controls will be recruited among students at Lund University, Lund, Sweden.
Key inclusion criteria (5 listed)
- One year after ACL reconstruction (ACLR)
- With or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury)
- Age 18-35 years
- Age 18-35 years
- No previous injuriy or surgery to either knee
Key exclusion criteria (8 listed)
- Less than 10 months after ACLR
- More than 16 months after ACLR
- Injury or surgery to other knee (e.g., ACL, meniscal)
- Previous knee surgery index knee
- Previous serious knee injury index knee resulting in pain, swelling, and/or requiring inpatient or outpatient health care (e.g., ACLR, meniscus, patella luxation)
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 |
|---|---|---|
| Measures of muscle functionThe participants will be assessed with various measures of muscle function at baseline and at follow up including: Isokinetic knee muscle strength, Isometric strength of trunk and lower extremity, single-leg hop for distance (SLHD), side hop, postural orientation errors (single leg-squat, stair descending, forward lunge, SLHD), hip and ankle range of motion, and muscular activation patterns. | Other | SHIELD |
Primary outcome
Patient-reported pain
Time frame: Change from baseline to 2-year follow up
Knee Osteoarthritis Outcome Score (KOOS) subscale pain
1 secondary outcome
Compositional MRI (T2 relaxation time and 3DPD)
Time frame: Change from baseline to 2-year follow up
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 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Eva Ageberg, PhD principal investigator
Department of Health Sciences, Lund University, PO Box 157, 221 00 Lund, Sweden
May Arna Risberg, PhD principal investigator
Oslo University Hospital, Division of Orthopedic Surgery, PO.Box 4956 Nydalen, 0424 Oslo, Norway
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Anterior Cruciate Ligament Injury, run by Lund University at 2 sites in 2 countries.
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 5 inclusion and 8 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. 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?
Patient-reported pain (time frame: Change from baseline to 2-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.