Clinical trial NCT06593912: Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols
Official title: Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tendon Tear
Tendon Rupture
Tendon Injuries
Surgery
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Capio Group
name: ATLEVA Fotcenter
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study comparing two different immobilization protocols.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

\* Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle

Exclusion Criteria:

* Extensive surgery needed, such as for example heel osteotomy
* Previous surgery in the affected area
* Previous injury in the healthy foot/leg that impairs function
* Neuromuscular disease
* Impaired language comprehension
* Age under 18

Primary outcomes:
measure: NRS
timeFrame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
Secondary outcomes:
measure: Calf circumference
timeFrame: Preoperative and 6 months, 12 months and 24 months postoperative.
measure: Range of motion
timeFrame: Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.
measure: Balance
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Biomechanical evaluation
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Electromyography (EMG)
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Cutting test
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Heel-rise work test
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Background questions
timeFrame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
measure: The Self-Reported Foot and Ankle Score (SEFAS)
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: Physical Activity Scale (PAS)
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Orthopedics
Study officials:
affiliation: Sahlgrenska University Hospital/Gothenburg University
name: Katarina Nilsson Helander, Ass prof
role: PRINCIPAL_INVESTIGATOR
References: