Anterior Cruciate Ligament InjuryNCT00198042
Bone Tunnel Widening Following ACL Reconstruction
A study testing Surgical reconstruction of the ACL in people with Anterior Cruciate Ligament Injury and Knee Injuries, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Knee Injuries
- What is being tested?
- Surgical reconstruction of the ACL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals within the age range of 18 to 55 years who are diagnosed with anterior cruciate insufficiency and have decided to undergo ACL reconstruction using autogenous graft will be included in the study.
Who cannot join
- Individuals that have previous knee surgeries, multi-ligament injuries, systemic ligament disorders such as Ehlers Danlos syndrome or connective tissue disorders will be excluded from the study.
- Individuals who are pregnant or expect to be pregnant during the course of the study or who are especially concerned with X-ray exposure should also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts.
Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the tendon remodels within the bone tunnels.
Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.
Read the detailed description
This will be a prospective study for patients undergoing ACL reconstruction using bone-patella tendon-bone graft, hamstring graft or achilles allograft. Each group will have ACL reconstruction with fixation using bioabsorbable interference screws on the femoral and tibial side. Patients will be evaluated on the day of surgery, 6, 12, 24, 52 and 104 weeks post-operatively. Evaluations will include pre-operative regional and standard bone mineral density measurements, post-operative MRI evaluation of tunnel dimensions and bone-tendon interface, radiographic evaluation of tunnel dimensions and routine clinical follow-up.
Interventions or Observations - outline specific procedures, treatments and/or interventions, as well as sources of research material to be utilized, which will involve human subjects or human materials that will be part of this research project.
This study will require a pre-operative bone mineral density measurement in the Nuclear Medicine Division of the Department of Radiology at HSS. Standard measurements of the femoral neck, spine as well as regional studies of the distal femur and proximal tibia of the injured knee will be performed.
On the day of surgery, the patient will undergo ACL reconstruction using bioabsorbable interference screw fixation of the hamstring, bone-patella tendon-bone graft, or achilles allograft. This is a standard procedure. The choice of graft type (hamstring, bone-patella tendon-bone graft, or achilles allograft) will be discussed with the patients and the patient will decide graft type pre-operatively. In this study, we will standardize the fixation method by using bioabsorbable interference screws. Post-operatively, the patient will undergo a limited MRI scan to evaluate the tunnel dimensions as well as graft placement prior to discharge from the hospital.
During the patients' 6 weeks, 12 weeks and 24 weeks clinical follow-up, they will be evaluated by their orthopaedic surgeon for clinical progress. Standard radiographs will be obtained of the patient's knee at the 6 weeks and 24 weeks follow-up visit. These are standard radiographic evaluations and are of no additional charge to the patients. We will utilize these images for radiographic measurements of tunnel expansion. During these visits, the patients will also undergo limited MRI scan of the femoral tunnel and tibia tunnel. With the serial MRI images, we will be able to make accurate measurements of the femoral and tibial tunnels. In addition, we will be able to evaluate the bone-tendon interface as well as the maturation of the intra-articular portion of the ACL graft. At 24, 52 and 104 weeks the patients will also be given standard IKDC and Lysholm clinical knee outcome questionnaires and will have objective stability measurements of both the operative and non-operative knees using a KT-1000 instrument.
Overall Study Protocol:
Pre-operative work-up
- Bone mineral density measurement by D.E.X.A.
Day of Surgery:
- ACL reconstruction using bioabsorbable interference screws
- Limited CT scans to quantitate tunnel dimensions
6 weeks post-operatively
- Regular clinical follow-up
- Regular plain radiographs to quantitate tunnel dimensions
- Limited MRI scans to quantitate tunnel dimensions
12 weeks post-operatively
- Regular clinical follow-up
- Limited MRI scans to quantitate tunnel dimensions
24 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Regular plain radiographs to quantitate tunnel dimensions
- MRI study to evaluate tendon-bone interface, graft maturation, tunnel dimensions and trabecular remodeling
- Patients will answer IKDC and Lysholm knee questionnaires
52 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Patients will answer IKDC and Lysholm knee questionnaires
- Limited MRI
104 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Patients will answer IKDC and Lysholm knee questionnaires
- Limited MRI
Number of Subjects (power justification for numbers)
A power analysis was performed to determine the number of subjects needed to determine significance between the hamstring and bone-patella tendon-bone group. Data from previous studies demonstrate tunnel widening up to 77 ± 28% following ACL reconstruction using hamstring tendons. We estimate that a 30% decrease in this amount of tunnel widening would be clinically significant. This extrapolates to a 54% increase in tunnel dimensions. Using these estimations, a power of 0.80 with α = 0.5 is achieved using 20 subjects per group (BPTB versus hamstring).
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injuries
- Being tested
- Surgical reconstruction of the ACL
- Keywords
- ACL, Tunnel, Widening
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reconstruction of the ACLProcedure or surgery
Surgical reconstruction of the ACL
| Study group | Role | What they receive |
|---|---|---|
| Surgical Reconstruction of the ACL | Experimental | Not described Receives: Procedure: Surgical reconstruction of the ACL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Tunnel Diameter
Bone tunnel diameter measured on MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Inion Oy
- Responsible party
- Sponsor
- Investigators
- Scott Rodeo, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198042
- Sponsor's protocol ID
- 22129
- Status last verified
- May 2017
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Tunnel Widening Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00198042
- Acronym / sponsor ID
- 22129
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injuries
- Keywords
- ACL, Tunnel, Widening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Inion Oy
- Study start
- Jun 2004
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts.
Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the tendon remodels within the bone tunnels.
Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.
Detailed description
This will be a prospective study for patients undergoing ACL reconstruction using bone-patella tendon-bone graft, hamstring graft or achilles allograft. Each group will have ACL reconstruction with fixation using bioabsorbable interference screws on the femoral and tibial side. Patients will be evaluated on the day of surgery, 6, 12, 24, 52 and 104 weeks post-operatively. Evaluations will include pre-operative regional and standard bone mineral density measurements, post-operative MRI evaluation of tunnel dimensions and bone-tendon interface, radiographic evaluation of tunnel dimensions and routine clinical follow-up.
Interventions or Observations - outline specific procedures, treatments and/or interventions, as well as sources of research material to be utilized, which will involve human subjects or human materials that will be part of this research project.
This study will require a pre-operative bone mineral density measurement in the Nuclear Medicine Division of the Department of Radiology at HSS. Standard measurements of the femoral neck, spine as well as regional studies of the distal femur and proximal tibia of the injured knee will be performed.
On the day of surgery, the patient will undergo ACL reconstruction using bioabsorbable interference screw fixation of the hamstring, bone-patella tendon-bone graft, or achilles allograft. This is a standard procedure. The choice of graft type (hamstring, bone-patella tendon-bone graft, or achilles allograft) will be discussed with the patients and the patient will decide graft type pre-operatively. In this study, we will standardize the fixation method by using bioabsorbable interference screws. Post-operatively, the patient will undergo a limited MRI scan to evaluate the tunnel dimensions as well as graft placement prior to discharge from the hospital.
During the patients' 6 weeks, 12 weeks and 24 weeks clinical follow-up, they will be evaluated by their orthopaedic surgeon for clinical progress. Standard radiographs will be obtained of the patient's knee at the 6 weeks and 24 weeks follow-up visit. These are standard radiographic evaluations and are of no additional charge to the patients. We will utilize these images for radiographic measurements of tunnel expansion. During these visits, the patients will also undergo limited MRI scan of the femoral tunnel and tibia tunnel. With the serial MRI images, we will be able to make accurate measurements of the femoral and tibial tunnels. In addition, we will be able to evaluate the bone-tendon interface as well as the maturation of the intra-articular portion of the ACL graft. At 24, 52 and 104 weeks the patients will also be given standard IKDC and Lysholm clinical knee outcome questionnaires and will have objective stability measurements of both the operative and non-operative knees using a KT-1000 instrument.
Overall Study Protocol:
Pre-operative work-up
- Bone mineral density measurement by D.E.X.A.
Day of Surgery:
- ACL reconstruction using bioabsorbable interference screws
- Limited CT scans to quantitate tunnel dimensions
6 weeks post-operatively
- Regular clinical follow-up
- Regular plain radiographs to quantitate tunnel dimensions
- Limited MRI scans to quantitate tunnel dimensions
12 weeks post-operatively
- Regular clinical follow-up
- Limited MRI scans to quantitate tunnel dimensions
24 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Regular plain radiographs to quantitate tunnel dimensions
- MRI study to evaluate tendon-bone interface, graft maturation, tunnel dimensions and trabecular remodeling
- Patients will answer IKDC and Lysholm knee questionnaires
52 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Patients will answer IKDC and Lysholm knee questionnaires
- Limited MRI
104 weeks post-operatively
- Regular clinical follow-up and KT-1000 measurements
- Patients will answer IKDC and Lysholm knee questionnaires
- Limited MRI
Number of Subjects (power justification for numbers)
A power analysis was performed to determine the number of subjects needed to determine significance between the hamstring and bone-patella tendon-bone group. Data from previous studies demonstrate tunnel widening up to 77 ± 28% following ACL reconstruction using hamstring tendons. We estimate that a 30% decrease in this amount of tunnel widening would be clinically significant. This extrapolates to a 54% increase in tunnel dimensions. Using these estimations, a power of 0.80 with α = 0.5 is achieved using 20 subjects per group (BPTB versus hamstring).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Reconstruction of the ACL | Experimental | Procedure: Surgical reconstruction of the ACL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals within the age range of 18 to 55 years who are diagnosed with anterior cruciate insufficiency and have decided to undergo ACL reconstruction using autogenous graft will be included in the study.
Key exclusion criteria (2 listed)
- Individuals that have previous knee surgeries, multi-ligament injuries, systemic ligament disorders such as Ehlers Danlos syndrome or connective tissue disorders will be excluded from the study.
- Individuals who are pregnant or expect to be pregnant during the course of the study or who are especially concerned with X-ray exposure should also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical reconstruction of the ACLSurgical reconstruction of the ACL | Procedure or surgery | Surgical Reconstruction of the ACL |
Primary outcome
Bone Tunnel Diameter
Time frame: 2 years
Bone tunnel diameter measured on MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Rodeo, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reconstruction of the ACL in people with Anterior Cruciate Ligament Injury and Knee Injuries, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Tunnel Diameter (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.