Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522659
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MULTI-LIG
Brief Summary:
Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenks classification Knee Dislocation into KD 1 KD 2 KD 3 and KD 4 These types of injuries can have devastating consequences on the individuals quality of life affecting their ability to return to sports and perform daily activities
In the literature there is still no consensus on the management of these types of traumas both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment if at all
The instability resulting from multiligament knee injuries is poorly tolerated by patients who find their daily activities limited It is also well known that this instability can dramatically accelerate the development of osteoarthritis leading to the need for joint replacement surgery even in young individuals thus increasing the likelihood of revisions and re-operations over time
Due to the lack of standardized and satisfactory treatment the economic cost of the outcomes of multiligament knee injuries is particularly high A recent study by XXX showed that only XXX of individuals are able to return to work The rate of participation in sports is even lower which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity diabetes and cardiovascular diseases
The choice of surgical treatment aims to eliminate the patients subjective feeling of instability and to repair when possible or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known
In the literature there is still no consensus on the management of these types of traumas both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment if at all
The instability resulting from multiligament knee injuries is poorly tolerated by patients who find their daily activities limited It is also well known that this instability can dramatically accelerate the development of osteoarthritis leading to the need for joint replacement surgery even in young individuals thus increasing the likelihood of revisions and re-operations over time
Due to the lack of standardized and satisfactory treatment the economic cost of the outcomes of multiligament knee injuries is particularly high A recent study by XXX showed that only XXX of individuals are able to return to work The rate of participation in sports is even lower which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity diabetes and cardiovascular diseases
The choice of surgical treatment aims to eliminate the patients subjective feeling of instability and to repair when possible or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None