Health TrialsbyHealthPanel

Non- vs Partial Controlled Weightbearing After Multiple Knee 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 isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 14 years old, <60

Reconstruction of PCL alone

Reconstruction of MCL alone

Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))

Disqualifiers

< 14 years old

>60 years old

Pregnant

Revision PCL reconstructions

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: Non-weightbearing for the first six weeks after surgeryActive comparator 1 intervention
Group B: Partial 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 radiographs

Time frame
Pre-operative
2

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

stress radiographs

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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