Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593912
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Patients with surgery of a peroneal tendon injury in Gothenburg Sweden will be randomized to one of two different postoperative protocols Before and after surgery the patients will perform biomechanical evaluation and also fill out questionnaires including PROMs All evaluations will be performed on both limbs
Detailed Description:
Patients admitted for surgery because of peroneal tendon injury will be randomized to one of two postoperative immobilization protocols In group A the patients will use a cast for 6 weeks after surgery In group B the patients will use a cast for 3 weeks followed by a Air Stirrup for 3 weeks The patients in group B will start unloaded range of motion 3 weeks after surgery Both groups are allowed to weight-bear directly after surgery The patients will be evaluated before and several times after surgery Patient-reported outcome measures PROMs will be used to evaluate changes in patient quality of life between the two interventions A biomechanical evaluation of the ankle knee and hip kinematics and kinetics during walking running and walking will also be performed before and repeatedly after surgery
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