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NCT Number: NCT05073276

Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

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.

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Key information

Age range

14 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location status: Recruiting

Location contact

Becky Stone

CONTACT

[email protected]

952-456-7136

Robert F LaPrade, MD, PhD

CONTACT

About this study

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:

  • non-weightbearing
  • partial weightbearing

An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.

Specific Aims

  • Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
  • Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
  • Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.

The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 14 years old, <60
  • Reconstruction of PCL alone
  • Reconstruction of MCL alone
  • Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
  • Reconstruction of multiligament injuries (ACL+MCL)
  • 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.

Exclusion criteria

  • < 14 years old
  • >60 years old
  • Pregnant
  • Revision PCL reconstructions
  • Previous or concurrent vascular injury (vascular bypass procedure)
  • Associated fractures requiring concurrent surgery
  • Concurrent meniscal root or radial repair surgery

Treatment and study plan

Physical Therapy

Other

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

Primary outcomes

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

    Time frame: Pre-operative

    stress radiographs

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

    Time frame: 6 months post-surgery

    stress radiographs

Secondary outcomes

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

    Time frame: Baseline and 6 months

    Pain scale 0-100

  2. Measurements by physical therapists (Edema, thigh circumference)

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

    Measurements with tape

  3. Measurements by physical therapists (range of motion)

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

    Measurements with goniometer

  4. Measurements by physical therapists (Quadriceps strength, gait analysis)

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

    Measurements by biomechanics lab

  5. Patient reported outcome scores

    Time frame: Baseline, 3 months, 6 months, 1 year

    Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

Becky McGaver

CONTACT

[email protected]

952-456-7136

Kayla Seiffert

CONTACT

[email protected]

952-456-7085

Sponsors and collaborators

Lead sponsor

Twin Cities Orthopedics

Other

Registry information

Official study title

Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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