NCT05073263

Brief Summary

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

6 years

First QC Date

September 14, 2021

Last Update Submit

November 20, 2024

Conditions

Knee Injuries

Keywords

fibular collateral ligament (FCL)anterior cruciate ligament (ACL)

Outcome Measures

Primary Outcomes (2)

  • Gapping (mm) measured on Standard of Care Varus stress radiographs

    stress radiograph

    Pre-operative

  • Gapping (mm) measured Standard of Care Varus stress radiographs

    stress radiograph

    6 months post-surgery

Secondary Outcomes (5)

  • Numeric Pain Scale (NPS) (0-10 rating)

    Baseline and 6 months

  • Measurements by physical therapists (Edema, thigh circumference)

    4,7, and 10 months after surgery

  • Measurements by physical therapists (Range of Motion)

    4,7, and 10 months after surgery

  • Measurements by physical therapists (Quadriceps strength, gait analysis)

    4,7, and 10 months after surgery

  • Patient reported outcome scores

    Baseline, 3 months, 6 months, 1 year

Study Arms (2)

Partial weight -bearing for the first six weeks after surgery

ACTIVE COMPARATOR

Partial weightbearing will be defined as 40% of the patient's body weight.

Other: Physical Therapy

Full weight -bearing for the first six weeks after surgery

EXPERIMENTAL

If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.

Other: Physical Therapy

Interventions

Physical TherapyOTHER

Patient is randomized to the weightbearing group the day after surgery.

Full weight -bearing for the first six weeks after surgeryPartial weight -bearing for the first six weeks after surgery

Eligibility Criteria

Age14 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ≥ 14 years old, \<60
  • Reconstruction of FCL alone
  • Combined FCL + ACL reconstructions
  • Males or females
  • Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if:

  • \< 14 years old, \> 60
  • Pregnant
  • Revision FCL reconstructions
  • Concurrent biceps femoris or lateral capsular repairs
  • Concurrent PCL or MCL reconstructions
  • Concomitant meniscus root or radial repair surgery with transtibial technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Robert F LaPrade, MD, PhD

    Twin Cities Orthopedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Becky Stone

CONTACT

952-456-7136research@tcomn.com

Kayla Seiffert

CONTACT

952-456-7085research@tcomn.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 11, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)