Meniscal TearNCT05557916
Rehabilitation With or Without Knee Orthosis Following Meniscal Repair
A study testing Standard rehab and accelerated rehab group in people with Meniscal Tear, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- Standard rehab and accelerated rehab group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2022to Dec 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.
Who cannot join
- Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
- Previous meniscal repair in the affected meniscus
- BMI over 30
Trial locations and contacts
2 sites in 1 country.
Christoffer Von Essen, MD contact
Sweden2 sites, 2 recruiting
- Recruiting
Centrum för idrottsforskning och utbildning (CIFU)
Stockholm, 11427
Anders Stålman, +46736665957, anders.stalman@ki.se
Sebastian McCallum, MD
- Recruiting
Karolinska University Hospital
Stockholm, 141 86
Anders Stålman, MD PhD, +46736994573, anders.stalman@ki.se
Anders Stålman, MD, PhD
About this study
Official title: A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.
Read the detailed description
The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.
The study design is a prospective randomized study with equal groups.
A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.
Randomization process and study design will be done according to the CONSORT guidelines.
- Conditions
- Meniscal Tear
- Being tested
- Standard rehab, accelerated rehab group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabOther
Standard rehab protocol including knee orthosis following meniscal repair
accelerated rehab groupOther
accelerated rehab group, no orthosis
| Study group | Role | What they receive |
|---|---|---|
| Standard rehab group | Active comparator | This group will follow the clinics standard rehab protocol, wherein they have a knee orthosis for six weeks, with flexion limited to 0-30 degress week 0-2, 0-60 degrees week 2-4 and 0-90 degrees week 4-6. Crouching is not permitted week 6-12. Receives: Other: Standard rehab |
| Accelerated rehab group | Active comparator | accelerated rehab group, wherein they are permitted to perform range of motion training within their comfort zone. Running is permitted after 8 weeks, contact sports 4 months postoperatively Receives: Other: accelerated rehab group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Biodex isokinetic quadriceps strength at 6 months
Patients will undergo Biodex Isokinetic measurement at 6 months
Measured: six months
Secondary outcomes (9)
Rates of failure
Rates of failure, defined as reoperation with meniscal resection within two years of the repair.
Measured: two years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results
Measured: preoperative, six months, two years
Change from baseline Biodex isokinetic quadriceps strength at 24 months
Patients will undergo Biodex Isokinetic measurement at 24 months
Measured: 2 years
Goniometric measurement: Knee flexion and extension
Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion
Measured: 2 weeks, 6 weeks, 6 months, 2 years
IKDC
Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results
Measured: Pre-operative, 6 months, 2 years
Tegner activity score
Patients will complete the Tegner activity score at specific time points to evaluate Activity in sports throughout treatment, Assesses activity level with specific emphasis on knee; scores range from 1 (least strenuous activity) to 10 (high knee demanding activity on professional sports level)
Measured: Pre-operative, 6 months, 2 years
Lysholm score
Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results
Measured: Pre-operative, 6 months, 2 years
Measurement of circumference of the knee
Circumference of the knee will be measured at mid-patella and 15cm above superior border of patella. They will be compared with contralateral knee to compare swelling.
Measured: Pre-operative, 6 weeks, 3 months, 6 months, 2 years
Functional knee tests
patients will undergo functional knee tests (ie Single hop test for difference, 30s chair-stand test
Measured: 6 weeks, 6 months, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Stalman, Karolinska Institutet
- Investigators
- Erik Rönnblad, Study director, Centrum för idrottsforskning och utbildning (CIFU) Adress: Valhallavägen 91, 11427 Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557916
- Sponsor's protocol ID
- Meniscal suture orthosis study
- Status last verified
- Sep 2022
- First submitted
- 20 Feb 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
- ClinicalTrials.gov ID
- NCT05557916
- Acronym / sponsor ID
- Meniscal suture orthosis study
- Conditions
- Meniscal Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Sep 2022 (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.
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.
Detailed description
The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.
The study design is a prospective randomized study with equal groups.
A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.
Randomization process and study design will be done according to the CONSORT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Standard rehab group | Active comparator | Other: Standard rehabThis group will follow the clinics standard rehab protocol, wherein they have a knee orthosis for six weeks, with flexion limited to 0-30 degress week 0-2, 0-60 degrees week 2-4 and 0-90 degrees week 4-6. Crouching is not permitted week 6-12. |
| Accelerated rehab group | Active comparator | Other: accelerated rehab groupaccelerated rehab group, wherein they are permitted to perform range of motion training within their comfort zone. Running is permitted after 8 weeks, contact sports 4 months postoperatively |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.
Key exclusion criteria (3 listed)
- Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
- Previous meniscal repair in the affected meniscus
- BMI over 30
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 |
|---|---|---|
| Standard rehabStandard rehab protocol including knee orthosis following meniscal repair | Other | Standard rehab group |
| accelerated rehab groupaccelerated rehab group, no orthosis | Other | Accelerated rehab group |
Primary outcome
Change from baseline Biodex isokinetic quadriceps strength at 6 months
Time frame: six months
Patients will undergo Biodex Isokinetic measurement at 6 months
9 secondary outcomes
Rates of failure
Time frame: two years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: preoperative, six months, two years
Change from baseline Biodex isokinetic quadriceps strength at 24 months
Time frame: 2 years
Goniometric measurement: Knee flexion and extension
Time frame: 2 weeks, 6 weeks, 6 months, 2 years
IKDC
Time frame: Pre-operative, 6 months, 2 years
Tegner activity score
Time frame: Pre-operative, 6 months, 2 years
Lysholm score
Time frame: Pre-operative, 6 months, 2 years
Measurement of circumference of the knee
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 2 years
Functional knee tests
Time frame: 6 weeks, 6 months, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Christoffer Von Essen, MD contact
Erik Rönnblad study director
Centrum för idrottsforskning och utbildning (CIFU) Adress: Valhallavägen 91, 11427 Stockholm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehab and accelerated rehab group in people with Meniscal Tear, run by Karolinska Institutet at 2 sites in Sweden.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian D McCallum, MBBS (+46760393379, mccallum.seb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Biodex isokinetic quadriceps strength at 6 months (time frame: six months). 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 28 Sep 2022.