NCT05991557

Brief Summary

The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 20, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

August 6, 2023

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • peronei muscle strength testing using handheld dynamometer

    power of plantar flexion and eversion of foot and ankle

    preoperative, three months postoperative and six months postoperative

Study Arms (1)

treatment arm

EXPERIMENTAL

peroneus longus autograft

Procedure: peroneus longus autograft

Interventions

Peroneus longus tendon graft will be harvested with a longitudinal skin incision at 2 to 3 cm (2 finger-breadths) above and 1 cm (1 finger-breadth) behind the lateral malleolus, followed by superficial fascia incision in line with skin incision followed by incision of the tendon sheath proximal to the retinaculum. The peroneus longus and peroneus brevis tendons will be then identified. The tendon division location marked at 2 to 3 cm above the level of the lateral malleolus.The peroneus longus tendon will be exposed on its posterolateral surface through the incision after carefully incising the fascia

treatment arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
  • people with asymptomatic ankle and foot pre and post injury

You may not qualify if:

  • Associated ankle and/or foot fractures.
  • Associated hip or pelvic fractures
  • Abnormal ankle function pre-injury.
  • Contralateral limb fractures
  • Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
  • Presence of neurological condition that result in spasticity or any abnormal lower limb muscles tone.
  • Any condition that would preclude the ability to comply with post-operative guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 20, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations