NCT07079254

Brief 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". 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
239mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Oct 2023Dec 2045

Study Start

First participant enrolled

October 7, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2045

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

12.2 years

First QC Date

July 13, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

MeniscusRe-operationBucket-handleOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Re-operation

    Re-operation for meniscus injury/lesion

    2-10 years

Secondary Outcomes (2)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    From 6 months to 10 years

  • Osteoarthritis in the knee

    10 years

Interventions

The meniscus bucket-handle injury will either be treated with meniscus suture or partial meniscectomy

The meniscus bucket-handle injury wil be treated with either meniscus suture or partial meniscectomy

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • years or above.
  • Displaced longitudinal bucket-handle tear including the posterior horn on MRI and a knee extension deficit.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Region Skåne, Orthopaedic department Kristianstad/Hässleholm

Hässleholm, Skåne County, Sweden

RECRUITING

Region Skåne, Skåne University Hospital

Malmo, Skåne County, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ola Svejme, MD, PhD

    Lund University, Department of Orthopaedics, Clinical Sciences, Malmö, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Alerskans, MD

CONTACT

Ola Svejme, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 22, 2025

Study Start

October 7, 2023

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2045

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Contains sensitive data such as social security number and surgery references, etc

Locations