Health TrialsbyHealthPanel

Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

ConditionKnee Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-59
SponsorTwin Cities Orthopedics

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 14 years old, <60

Reconstruction of FCL alone

Combined FCL + ACL reconstructions

Males or females

Disqualifiers

< 14 years old, > 60

Pregnant

Revision FCL reconstructions

Concurrent biceps femoris or lateral capsular repairs

Trial design

Design model

Single group

Treatments tested in this trial

  • Physical Therapy

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Partial weight -bearing for the first six weeks after surgeryActive comparator 1 intervention
Group B: Full weight -bearing for the first six weeks after surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

stress radiograph

Time frame
Pre-operative
2

Gapping (mm) measured Standard of Care Varus stress radiographs

stress radiograph

Time frame
6 months post-surgery

Secondary outcomes

1

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

Pain scale 0-100

Time frame
Baseline and 6 months
2

Measurements by physical therapists (Edema, thigh circumference)

Measurements with tape

Time frame
4,7, and 10 months after surgery
3

Measurements by physical therapists (Range of Motion)

Measurements with goniometer

Time frame
4,7, and 10 months after surgery
4

Measurements by physical therapists (Quadriceps strength, gait analysis)

Measurements by biomechanics lab

Time frame
4,7, and 10 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Twin Cities Orthopedics

Lead sponsor

Source ClinicalTrials.gov
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