NCT07762989

Brief Summary

This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Twenty participants aged 18 to 55 years will be evaluated at postoperative 6-8 weeks, 3 months, and 6 months. The donor limb and the contralateral non-donor limb will be compared using surface electromyography of the peroneus longus, force-platform measures of postural control, inertial-sensor gait analysis, active ankle joint-position sense testing, and clinical and patient-reported foot and ankle function measures. The study does not assign the surgical procedure or rehabilitation treatment.

Trial Health

63
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 22, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

peroneus longus tendon autograftdonor anklesensorimotor functionsurface electromyographypostural controlproprioceptiongait analysis

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Center of Pressure Velocity During Single-Leg Balance

    Mean center of pressure (CoP) velocity during a 10-second single-leg stance, assessed separately with eyes open and eyes closed on KFORCE Plates. Each limb will be tested in three trials, and the mean for each condition will be used. Values are expressed in millimeters per second (mm/s); lower values indicate less postural sway. Change from the postoperative 6-8-week assessment to 3 and 6 months and donor-versus-contralateral limb differences will be evaluated.

    Postoperative 6-8 weeks, 3 months, and 6 months

Secondary Outcomes (18)

  • Change in CoP Path Length During Single-Leg Balance

    Postoperative 6-8 weeks, 3 months, and 6 months

  • Change in CoP Ellipse Area During Single-Leg Balance

    Postoperative 6-8 weeks, 3 months, and 6 months

  • Change in Mean CoP Velocity During Double-Leg Balance

    Postoperative 6-8 weeks, 3 months, and 6 months

  • Change in CoP Path Length During Double-Leg Balance

    Postoperative 6-8 weeks, 3 months, and 6 months

  • Change in CoP Ellipse Area During Double-Leg Balance

    Postoperative 6-8 weeks, 3 months, and 6 months

  • +13 more secondary outcomes

Study Arms (1)

Peroneus Longus Tendon Autograft ACLR Cohort

Adults after primary unilateral ACL reconstruction using a peroneus longus tendon autograft. Participants will undergo observational assessments at postoperative 6-8 weeks, 3 months, and 6 months. Donor-limb measures will be compared with measurements from the contralateral non-donor limb. No intervention is assigned by the study.

Procedure: Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon Autograft

Interventions

Participants undergo primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft as part of their routine clinical care. The graft choice and surgical procedure are determined by the treating orthopedic surgeon independently of study participation. The study does not assign or modify the graft choice, surgical technique, or postoperative rehabilitation. Participants receive routine postoperative rehabilitation according to their clinical needs, while donor-ankle sensorimotor recovery is assessed prospectively at 6-8 weeks, 3 months, and 6 months after surgery.

Peroneus Longus Tendon Autograft ACLR Cohort

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 to 55 years who have undergone primary unilateral anterior cruciate ligament reconstruction using a peroneus longus tendon autograft as part of routine clinical care and are referred to the Sports Health Unit, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, for postoperative rehabilitation and functional assessment. Eligible participants will be enrolled consecutively during the study period.

You may qualify if:

  • Age 18 to 55 years.
  • Unilateral primary anterior cruciate ligament tear confirmed by clinical examination and magnetic resonance imaging.
  • Primary anterior cruciate ligament reconstruction performed using a peroneus longus tendon autograft.
  • Able and willing to attend the postoperative assessments at 6-8 weeks, 3 months, and 6 months.
  • Written informed consent provided before study participation.

You may not qualify if:

  • Multiligament knee injury.
  • Previous surgery on the index knee or donor ankle.
  • Pre-existing ankle instability or major foot or ankle pathology.
  • Neurological or neuromuscular disease.
  • Inflammatory or systemic disease that may affect the assessments.
  • Major lower-extremity deformity that may affect the assessments.
  • Unable to complete the postoperative rehabilitation program or scheduled follow-up assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Sports Health Unit

Çankaya, Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Dudu Ozdemir Can, Msc

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Nihan Karatas, Prof. Dr.

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Dudu Ozdemir Can, Msc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate, Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start (Estimated)

August 22, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

No individual participant data sharing plan has been specified for this study.

Locations