- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07079254
- Original Trial
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sofie Alerskans, MD
- Phone Number: +46 768-487639
- Email: sofie.alerskans@med.lu.se
Study Contact Backup
- Name: Ola Svejme, MD, PhD
- Phone Number: +46 722-106158
- Email: ola.svejme@skane.se
Study Locations
-
-
Skåne
-
Hässleholm, Skåne, Sweden
- Recruiting
- Region Skåne, Orthopaedic department Kristianstad/Hässleholm
-
Contact:
- Sofie Alerskans, MD
- Phone Number: +46768487639
- Email: sofie.alerskans@med.lu.se
-
Malmö, Skåne, Sweden
- Recruiting
- Region Skåne, Skåne University Hospital
-
Contact:
- Ola Svejme, MD, PhD
- Phone Number: +722 106158
- Email: ola.svejme@skane.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 15 years or above.
- Displaced longitudinal bucket-handle tear including the posterior horn on MRI and a knee extension deficit.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Re-operation
Time Frame: 2-10 years
|
Re-operation for meniscus injury/lesion
|
2-10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Osteoarthritis in the knee
Time Frame: 10 years
|
Radiological osteoarthritis
|
10 years
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: From 6 months to 10 years
|
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).
|
From 6 months to 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ola Svejme, MD, PhD, Lund University, Department of Orthopaedics, Clinical Sciences, Malmö, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-00059-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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