Knee InjuriesNCT00991588
Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction
An observational study of Knee Injuries, run by Sue Barber-Westin at 1 site in United States.
Trial summary
The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Injuries
- What is being tested?
- PCL, posterolateral reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 31 Dec 2018
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled for PCL and/or posterolateral reconstruction
Who may be able to join
- Complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation
- Rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation
- Patient willing to comply with postoperative rehabilitation program
Who cannot join
- Patient unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
About this study
Official title: Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee
The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. The outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. We hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.
Read the detailed description
Because injuries to the PCL and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. The majority of patients who sustain injury to these structures are treated conservatively. Unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. The investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. It is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. Especially in athletic individuals, PCL and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. Studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 Whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.
- Conditions
- Knee Injuries
- Being tested
- PCL, posterolateral reconstruction
- Keywords
- PCL, Posterolateral
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCL, posterolateral reconstructionProcedure or surgery
The operative procedures involve either a single- or double-strand PCL graft which is usually harvested from the patient's knee. In cases of multiple ligament procedures, allograft tissues may be used which are obtained from tissue banks certified by the American Associate of Tissue Banks and that have passed FDA inspection. The posterolateral structures, including the fibular collateral ligament (FCL), are reconstructed with one or two grafts, depending upon the severity of damage encountered at surgery.
| Study group | Role | What they receive |
|---|---|---|
| PCL, posterolateral reconstruction | All patients who are entered into study who receive a PCL and/or posterolateral knee ligament reconstruction Receives: Procedure: PCL, posterolateral reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination of knee giving-way
Measured: Minimum 2 years postoperatively
Secondary outcomes (4)
Posterior tibial translation
Measured: Minimum 2 years postoperative
Lateral tibiofemoral joint opening
Measured: Minimum 2 years postoperatively
External tibial rotation
Measured: Minimum 2 years postoperatively
Elimination of knee pain
Measured: Minimum 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startOct 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sue Barber-Westin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
- Investigators
- Frank Noyes, M.D., Principal investigator, Cincinnati Sportsmedicine Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991588
- Sponsor's protocol ID
- PCLPL-001
- Status last verified
- Jul 2019
- First submitted
- 6 Oct 2009
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee
- ClinicalTrials.gov ID
- NCT00991588
- Acronym / sponsor ID
- PCLPL-001
- Conditions
- Knee Injuries
- Keywords
- PCL, Posterolateral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sue Barber-WestinUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. The outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. We hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.
Detailed description
Because injuries to the PCL and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. The majority of patients who sustain injury to these structures are treated conservatively. Unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. The investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. It is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. Especially in athletic individuals, PCL and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. Studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 Whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCL, posterolateral reconstruction | – | Procedure: PCL, posterolateral reconstructionAll patients who are entered into study who receive a PCL and/or posterolateral knee ligament reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for PCL and/or posterolateral reconstruction
Key inclusion criteria (3 listed)
- Complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation
- Rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation
- Patient willing to comply with postoperative rehabilitation program
Key exclusion criteria (1 listed)
- Patient unwilling to participate
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 |
|---|---|---|
| PCL, posterolateral reconstructionThe operative procedures involve either a single- or double-strand PCL graft which is usually harvested from the patient's knee. In cases of multiple ligament procedures, allograft tissues may be used which are obtained from tissue banks certified by the American Associate of Tissue Banks and that have passed FDA inspection. The posterolateral structures, including the fibular collateral ligament (FCL), are reconstructed with one or two grafts, depending upon the severity of damage encountered at surgery. | Procedure or surgery | PCL, posterolateral reconstruction |
Primary outcome
Elimination of knee giving-way
Time frame: Minimum 2 years postoperatively
4 secondary outcomes
Posterior tibial translation
Time frame: Minimum 2 years postoperative
Lateral tibiofemoral joint opening
Time frame: Minimum 2 years postoperatively
External tibial rotation
Time frame: Minimum 2 years postoperatively
Elimination of knee pain
Time frame: Minimum 2 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Yes
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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.
Frank Noyes, M.D. principal investigator
Cincinnati Sportsmedicine Research and Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by Sue Barber-Westin 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 3 inclusion and 1 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 31 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Elimination of knee giving-way (time frame: Minimum 2 years postoperatively). 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 31 Jul 2019.