Knee InjuriesNCT00418964
Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures
A study testing Single bundle hamstring, Double bundle hamstring and Bone patellar tendon bone in people with Knee Injuries, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Single bundle hamstring, Double bundle hamstring and Bone patellar tendon bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Dec 2006to Jun 2011
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men above age 18-40 years old
- First ACL reconstruction surgery
- Single leg involvement
Who cannot join
- ACL injury less than 6 weeks as deleterious effect of the injury may affect the extension range
- Injury on Duty (IOD) cases
- Other associated injuries (Fractures, other ligaments involvement, neurovascular bundles injury),Chondral lesion with co-commitment intervention
- Concomitant meniscus repair in same operation, or within 3 months before the operation
- Significant OA changes
- Known chronic disease or receiving long term medications affecting bone metabolism, including anabolic steroids, medication for thyroid hormone therapy or osteoporosis
- Neurological deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional, Clinical & Radiological Outcome of Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Control Clinical Trial Studies Comparing Bone Patella Bone, Single Bundle and Double Bundle Method.
The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density and functional status.
Read the detailed description
Anterior cruciate ligament (ACL) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 cases performed per year in the United States. A large amount of sports injuries were related to ACL problem. As such, ACL injuries and treatment is still widely under intensive study.
Traditionally, ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft. Problems of knee pain, unstable fixation, rotational instability and degenerative changes were reported. Recently, the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed. However, results about the clinical, functional and radiological outcomes are limited.
The objective of this prospective pilot study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, skin sensation, bone mineral density and functional status.
Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited. Subjects will be randomly assigned to the three surgical groups by block randomization. Demographic information, parameters in recovery domain, functional domain and stability domain, isokinetic test, motion analysis domain, proprioception and radiographical measurements will be made at baseline and at day 1, week 2, week 4, week 8, month 3, month 5, 1 year and 2 years post-surgery. The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA.
- Conditions
- Knee Injuries
- Being tested
- Single bundle hamstring, Double bundle hamstring, Bone patellar tendon bone
- Keywords
- Anterior cruciate ligament rupture, Anterior cruciate ligament(A02.513.514.100)
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single bundle hamstringProcedure or surgery
Single bundle hamstring
Double bundle hamstringProcedure or surgery
Double bundle hamstring
Bone patellar tendon boneProcedure or surgery
Bone patellar tendon bone
| Study group | Role | What they receive |
|---|---|---|
| Single bundle hamstring | Experimental | Not described Receives: Procedure: Single bundle hamstring |
| Double bundle hamstring | Experimental | Not described Receives: Procedure: Double bundle hamstring |
| Bone patellar tendon bone | Active comparator | Not described Receives: Procedure: Bone patellar tendon bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC)Knee Form 2000 Score
It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.
Measured: 1 year
Secondary outcomes (1)
Percentage Distal Femoral Bone Mineral Density (BMD)Decrease
% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2011
- Study completionJun 2011
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 Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Lui, Chinese University of Hong Kong
- Investigators
- Kai Ming Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418964
- Sponsor's protocol ID
- CUHK00001
- Status last verified
- Mar 2012
- First submitted
- 4 Jan 2007
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Clinical & Radiological Outcome of Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Control Clinical Trial Studies Comparing Bone Patella Bone, Single Bundle and Double Bundle Method.
- ClinicalTrials.gov ID
- NCT00418964
- Acronym / sponsor ID
- CUHK00001
- Conditions
- Knee Injuries
- Keywords
- Anterior cruciate ligament rupture, Anterior cruciate ligament(A02.513.514.100)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Posted 20 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density and functional status.
Detailed description
Anterior cruciate ligament (ACL) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 cases performed per year in the United States. A large amount of sports injuries were related to ACL problem. As such, ACL injuries and treatment is still widely under intensive study.
Traditionally, ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft. Problems of knee pain, unstable fixation, rotational instability and degenerative changes were reported. Recently, the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed. However, results about the clinical, functional and radiological outcomes are limited.
The objective of this prospective pilot study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, skin sensation, bone mineral density and functional status.
Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited. Subjects will be randomly assigned to the three surgical groups by block randomization. Demographic information, parameters in recovery domain, functional domain and stability domain, isokinetic test, motion analysis domain, proprioception and radiographical measurements will be made at baseline and at day 1, week 2, week 4, week 8, month 3, month 5, 1 year and 2 years post-surgery. The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single bundle hamstring | Experimental | Procedure: Single bundle hamstring |
| Double bundle hamstring | Experimental | Procedure: Double bundle hamstring |
| Bone patellar tendon bone | Active comparator | Procedure: Bone patellar tendon bone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men above age 18-40 years old
- First ACL reconstruction surgery
- Single leg involvement
Key exclusion criteria (7 listed)
- ACL injury less than 6 weeks as deleterious effect of the injury may affect the extension range
- Injury on Duty (IOD) cases
- Other associated injuries (Fractures, other ligaments involvement, neurovascular bundles injury),Chondral lesion with co-commitment intervention
- Concomitant meniscus repair in same operation, or within 3 months before the operation
- Significant OA changes
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 |
|---|---|---|
| Single bundle hamstringSingle bundle hamstring | Procedure or surgery | Single bundle hamstring |
| Double bundle hamstringDouble bundle hamstring | Procedure or surgery | Double bundle hamstring |
| Bone patellar tendon boneBone patellar tendon bone | Procedure or surgery | Bone patellar tendon bone |
Primary outcome
International Knee Documentation Committee (IKDC)Knee Form 2000 Score
Time frame: 1 year
It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.
1 secondary outcome
Percentage Distal Femoral Bone Mineral Density (BMD)Decrease
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- 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.
Kai Ming Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single bundle hamstring, Double bundle hamstring and Bone patellar tendon bone in people with Knee Injuries, run by Chinese University of Hong Kong at 1 site in China.
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 7 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 27 Mar 2012. 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 China. 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 20 Mar 2012). 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?
International Knee Documentation Committee (IKDC)Knee Form 2000 Score (time frame: 1 year). 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 27 Mar 2012.