Initial Graft Tension and ACL Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Braden Fleming, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00434837
First received: February 9, 2007
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. The purpose of this study is to determine the effect of initial graft tension set during ACL reconstruction surgery on the progression of knee arthritis over at least a 7-year period.


Condition Intervention
Anterior Cruciate Ligament Rupture
Procedure: Initial graft tension during ACL reconstruction surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Radiographic joint space narrowing [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • MRI cartilage volume and thickness [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Knee injury and osteoarthritis outcome score [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee joint laxity [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Limb strength international knee documentation committee score [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • SF-36 health survey [ Time Frame: Year 3 ] [ Designated as safety issue: No ]
  • Muscle atrophy [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Whole Organ Magnetic Resonance Image Score [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: February 2004
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-tension
Low-tension (Group 1) participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Procedure: Initial graft tension during ACL reconstruction surgery
The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg. When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg. Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
Experimental: High-tension
High-tension (Group 2) participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Procedure: Initial graft tension during ACL reconstruction surgery
The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg. When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg. Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.

Detailed Description:

Damage to the ACL is a common injury that usually requires surgical reconstruction to restore function and prevent progression of post-traumatic osteoarthritis. However, the reconstruction procedure frequently causes degenerative changes to the knee joint over time. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. High tension would result in less joint motion during the initial healing stages, which may make the onset of arthritis less likely. On the other hand, high tension would result in increased compressive forces between the joint surfaces, which could lead to arthritis. The purpose of this study is to evaluate the effect of initial graft tension set during ACL reconstruction surgery on joint cartilage and the development of knee arthritis over at least a 7-year period.

Participants will include candidates for ACL reconstruction surgery using patellar tendon grafts. Participants will be randomly assigned to one of two treatment groups:

  • Low tension (Group 1) participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
  • High-tension (Group 2) participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.

Participants will enroll in this 7-year study 1 to 6 weeks prior to ACL surgery. There will be two preoperative study visits: one will include magnetic resonance imaging (MRI) and the other will include a knee evaluation, dynamic function testing, and questionnaires. Postoperative visits will occur immediately following surgery and at 6, 12, 36, 60, and 84 months following surgery. Strength testing, functional testing, x-rays, questionnaires, and a knee exam will occur at most postoperative visits. MRIs will occur at some postoperative visits. An additional group of participants with no evidence of knee injury will serve as a control. The control group will attend all study visits except for the 12-month visit. All participants may be followed for up to 10 years.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Groups 1 and 2:

  • ACL injury of only one knee (minor meniscal tears involving less than 1/3 of the meniscus are allowed)
  • Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles)
  • Tegner activity score of 5 or greater, indicating participant is at least moderately active

Exclusion Criteria for Groups 1 and 2:

  • ACL tear that has occurred more than 12 months prior to surgery
  • Moderate-sized fissures or lesions in knee articular cartilage
  • Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus)

Inclusion Criteria for the Control Group:

  • Tegner activity score of 5 or greater, indicating participant is at least moderately active

Exclusion Criteria for All Participants:

  • Previous injury to either knee
  • Increased laxity of the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL), as compared to the uninjured knee
  • Radiographic evidence of degenerative arthritis
  • Pregnancy
  • Any disease that might place a participant at high risk for articular cartilage damage (e.g., rheumatoid arthritis, osteoporosis, metabolic diseases)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434837

Locations
United States, Rhode Island
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States, 02903
Miriam Hospital/Brown University
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Braden C. Fleming, PhD Rhode Island Hospital/Brown Medical School
  More Information

Publications:

Responsible Party: Braden Fleming, Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00434837     History of Changes
Other Study ID Numbers: R01 AR047910, R01AR047910
Study First Received: February 9, 2007
Last Updated: November 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Rhode Island Hospital:
Knee
Ligament
ACL
Reconstruction
Cartilage
Osteoarthritis

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014