Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504680
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-03
Brief Title:
Results of 8 Strand Repair of Flexor Tendon Injuries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Results of 8 Strand Repair of Flexor Tendon Injuries Zone II With and Without Splinting of the Wrist A Randomized Controlled Trial
Status:
NOT_YET_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:
None
Brief Summary:
Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist
Detailed Description:
Flexor tendon injuries of the hand account for 30 of all hand injuries but are difficult to treat and are associated with frequent poor outcomes While major progress has been made with the treatment of these injuries current surgical treatment relies mostly on conventional suturing techniques with variable results concluding in re-operation rates of 12 and complication rate of up to 20 Restoration of tendon gliding is the goal when repairing flexor tendon injuries The tendon forces experienced during postoperative active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion Multistrand sutures typically four- or six-strand repairs may withstand much greater tension than conventional two-strand sutures during early active mobilization
However multistrand particularly eight-strand repair requires complicated surgical skills such repair is difficult Here we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches it affords the necessary tensile strength to prevent both gap formation and ultimate failure
The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength and it should not result in a bulky configuration which would affect tendon gliding
Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving Intensive supervision of a hand therapist is generally not required Notably improved outcomes have been achieved while preventing adhesions at the repair site
However multistrand particularly eight-strand repair requires complicated surgical skills such repair is difficult Here we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches it affords the necessary tensile strength to prevent both gap formation and ultimate failure
The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength and it should not result in a bulky configuration which would affect tendon gliding
Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving Intensive supervision of a hand therapist is generally not required Notably improved outcomes have been achieved while preventing adhesions at the repair site
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