Meniscus RuptureNCT07079254
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
An observational study of Meniscus Rupture and Meniscus Injury, run by Region Skane at 2 sites in Sweden.
Trial summary
The menisci of the knee joint are structures composed of cartilage and connective tissue, whose primary functions are to stabilize the joint and distribute weight across joint surfaces. In doing so, it helps protect the joint from osteoarthritis - a form of joint failure commonly referred to as "joint wear". Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Meniscus Rupture, Meniscus Injury, Osteoarthritis of Knee
- What is being tested?
- Meniscus suture and Partial meniscectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Oct 2023to Dec 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who present to the emergency department or the orthopaedic outpatient clinics at our hospitals with a knee extension deficit after trauma, with a clinically suspected bucket-handle meniscus rupture, are referred to a magnetic resonance imaging (MRI) within a week. Patients with a bucket-handle tear on the MRI, and no younger than 15 years, will be invited to participate in the study. Recruitment takes place at the outpatient clinic at the orthopaedic department at Skåne University Hospital in Malmö and the orthopaedic department at Hässleholm hospital.
Who may be able to join
- 15 years or above.
- Displaced longitudinal bucket-handle tear including the posterior horn on MRI and a knee extension deficit.
Who cannot join
- Patient younger than 15 years.
- Insufficient knowledge of the Swedish language.
- Per-operative findings including a bucket-handle rupture in combination with a complete radial rupture
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Skåne, Orthopaedic department Kristianstad/Hässleholm
Hässleholm, Skåne County
Sofie Alerskans, MD, +46768487639, sofie.alerskans@med.lu.se
- Recruiting
Region Skåne, Skåne University Hospital
Malmö, Skåne County
Ola Svejme, MD, PhD, +722 106158, ola.svejme@skane.se
About this study
Official title: Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy: A 10-year Observational Study
The menisci of the knee joint are structures composed of cartilage and connective tissue, whose primary functions are to stabilize the joint and distribute weight across joint surfaces. In doing so, it helps protect the joint from osteoarthritis - a form of joint failure commonly referred to as "joint wear". Meniscal surgeries are among the most common orthopaedic procedures performed both in Sweden and globally. Historically, damaged menisci were treated by removing the injured part. However, this approach is linked to early-onset osteoarthritis. Osteoarthritis affects approximately one-third of individuals over the age of 45 and ranks among the ten most common diagnoses in Europe based on years lived with disability. The knee is the most frequently affected joint, and the importance of the menisci in preserving knee function has become increasingly recognized.
In recent years, advances in surgical techniques have led to a shift towards meniscus-preserving procedures. A typical injury is the displaced meniscus, in which a large portion of the meniscus becomes detached from the joint capsule and wedges itself inside the joint, causing mechanical locking and preventing full extension. A displaced meniscus often loses its blood supply and suffers mechanical damage from being compressed between the joint surfaces. To preserve the meniscus and prevent irreversible damage, early surgical intervention is required. If the injury is too old or the tissue too damaged, the injured part of the meniscus must be removed, which significantly increases the risk of developing early knee osteoarthritis.
Read more
It remains unclear how soon surgery must be performed to successfully preserve the meniscus, and this likely depends on various other factors, including patient age, presence of additional joint injuries, and surgical technique. There is currently no reliable data on the proportion of displaced menisci that heal after meniscus-preserving surgery. However, studies suggest that 20-30% of repaired menisci require reoperation due to failed healing.
Given that displaced menisci are considered surgical emergencies, they pose a significant burden on healthcare systems already strained by limited access to urgent surgery. Meanwhile, ongoing development of surgical techniques raise ethical and logistical questions for health providers - especially as the scientific evidence for the benefits of some advanced treatments remains inconclusive.
Therefore, more research is needed to guide the optimal management of displaced bucket-handle lesions across a diverse patient population, taking into account age, activity level, and concurrent injuries. A key priority is to identify predictors of healing potential, particularly the time window during which surgical repair remains a viable option. With better knowledge, more menisci could potentially be preserved - reducing both the number of unnecessary re-operations and the long-term incidence of knee osteoarthritis.
- Conditions
- Meniscus Rupture, Meniscus Injury, Osteoarthritis of Knee
- Being tested
- Meniscus suture, Partial meniscectomy
- Keywords
- Meniscus, Re-operation, Bucket-handle, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus sutureProcedure or surgery
The meniscus bucket-handle injury will either be treated with meniscus suture or partial meniscectomy
Partial meniscectomyProcedure or surgery
The meniscus bucket-handle injury wil be treated with either meniscus suture or partial meniscectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation
Re-operation for meniscus injury/lesion
Measured: 2-10 years
Secondary outcomes (2)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome measure in the form of Knee Injury and Outcome Score (KOOS). A total score, called KOOS4, without the ADL scale, will be calculated. The scale ranges from 0 (worst) to 100 (best).
Measured: From 6 months to 10 years
Osteoarthritis in the knee
Radiological osteoarthritis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start7 Oct 2023
- Primary completionDec 2035 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus RuptureStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ola Svejme, MD, PhD, Principal investigator, Lund University, Department of Orthopaedics, Clinical Sciences, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079254
- Sponsor's protocol ID
- 2023-00059-01
- Other IDs
- 2023
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contains sensitive data such as social security number and surgery references, etc
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy: A 10-year Observational Study
- ClinicalTrials.gov ID
- NCT07079254
- Acronym / sponsor ID
- 2023-00059-01
- Conditions
- Meniscus Rupture, Meniscus Injury, Osteoarthritis of Knee
- Keywords
- Meniscus, Re-operation, Bucket-handle, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 22 Jul 2025 (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.
The menisci of the knee joint are structures composed of cartilage and connective tissue, whose primary functions are to stabilize the joint and distribute weight across joint surfaces. In doing so, it helps protect the joint from osteoarthritis - a form of joint failure commonly referred to as "joint wear". Meniscal surgeries are among the most common orthopaedic procedures performed both in Sweden and globally. Historically, damaged menisci were treated by removing the injured part. However, this approach is linked to early-onset osteoarthritis. Osteoarthritis affects approximately one-third of individuals over the age of 45 and ranks among the ten most common diagnoses in Europe based on years lived with disability. The knee is the most frequently affected joint, and the importance of the menisci in preserving knee function has become increasingly recognized.
In recent years, advances in surgical techniques have led to a shift towards meniscus-preserving procedures. A typical injury is the displaced meniscus, in which a large portion of the meniscus becomes detached from the joint capsule and wedges itself inside the joint, causing mechanical locking and preventing full extension. A displaced meniscus often loses its blood supply and suffers mechanical damage from being compressed between the joint surfaces. To preserve the meniscus and prevent irreversible damage, early surgical intervention is required. If the injury is too old or the tissue too damaged, the injured part of the meniscus must be removed, which significantly increases the risk of developing early knee osteoarthritis.
It remains unclear how soon surgery must be performed to successfully preserve the meniscus, and this likely depends on various other factors, including patient age, presence of additional joint injuries, and surgical technique. There is currently no reliable data on the proportion of displaced menisci that heal after meniscus-preserving surgery. However, studies suggest that 20-30% of repaired menisci require reoperation due to failed healing.
Given that displaced menisci are considered surgical emergencies, they pose a significant burden on healthcare systems already strained by limited access to urgent surgery. Meanwhile, ongoing development of surgical techniques raise ethical and logistical questions for health providers - especially as the scientific evidence for the benefits of some advanced treatments remains inconclusive.
Therefore, more research is needed to guide the optimal management of displaced bucket-handle lesions across a diverse patient population, taking into account age, activity level, and concurrent injuries. A key priority is to identify predictors of healing potential, particularly the time window during which surgical repair remains a viable option. With better knowledge, more menisci could potentially be preserved - reducing both the number of unnecessary re-operations and the long-term incidence of knee osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present to the emergency department or the orthopaedic outpatient clinics at our hospitals with a knee extension deficit after trauma, with a clinically suspected bucket-handle meniscus rupture, are referred to a magnetic resonance imaging (MRI) within a week. Patients with a bucket-handle tear on the MRI, and no younger than 15 years, will be invited to participate in the study. Recruitment takes place at the outpatient clinic at the orthopaedic department at Skåne University Hospital in Malmö and the orthopaedic department at Hässleholm hospital.
Key inclusion criteria (2 listed)
- 15 years or above.
- Displaced longitudinal bucket-handle tear including the posterior horn on MRI and a knee extension deficit.
Key exclusion criteria (3 listed)
- Patient younger than 15 years.
- Insufficient knowledge of the Swedish language.
- Per-operative findings including a bucket-handle rupture in combination with a complete radial rupture
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 |
|---|---|---|
| Meniscus sutureThe meniscus bucket-handle injury will either be treated with meniscus suture or partial meniscectomy | Procedure or surgery | – |
| Partial meniscectomyThe meniscus bucket-handle injury wil be treated with either meniscus suture or partial meniscectomy | Procedure or surgery | – |
Primary outcome
Re-operation
Time frame: 2-10 years
Re-operation for meniscus injury/lesion
2 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From 6 months to 10 years
Osteoarthritis in the knee
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. Contains sensitive data such as social security number and surgery references, etc
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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.
Ola Svejme, MD, PhD principal investigator
Lund University, Department of Orthopaedics, Clinical Sciences, Malmö, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Rupture and Meniscus Injury, run by Region Skane 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 2 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Alerskans, MD (+46 768-487639, sofie.alerskans@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation (time frame: 2-10 years). 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 13 Aug 2026.