Rupture of Anterior Cruciate LigamentNCT02771548
Biomechanical Analysis of Dynamic Tasks and Muscular Strength Following Anterior Cruciate Ligament Reconstruction
An observational study of Rupture of Anterior Cruciate Ligament, run by Dr Neil Welch ASCC at 1 site in Ireland.
Trial summary
Background Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an attempt to increase joint stability and facilitate athletes to return to sport (RTS). Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- Anterior Cruciate Ligament Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2014to Dec 2040
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Those who undergo anterior cruciate ligament reconstruction in the Sports Surgery Clinic, Dublin, and who meet the inclusion criteria, will be asked if they wish to participate in this study. Sports Surgery Clinic is a private hospital where over 750 ACL reconstructive surgeries take place each year. Many patients will travel from all over the country of Ireland to the clinic for the surgery, meaning there is a wide catchment area for participants.
Who may be able to join
- Active participants
- Anterior cruciate ligament reconstruction surgery in the Sports Surgery Clinic.
- Over the age of 13 years
Who cannot join
- Multiple orthopaedic injuries concurrently.
- Surgery outside of Sports Surgery Clinic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Sports Surgery Clinic
Dublin, Leinster
Neil B Welch, PhD, 00 353 1 526 2030, welchn2@upmc.ie
Thilina Vitherana, MSc, 00 353 1 526 2030, vitheranat@upmc.ie
About this study
Background
Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an attempt to increase joint stability and facilitate athletes to return to sport (RTS). Although ACLR is considered a relatively successful procedure, dynamic control risk factors and strength and power deficits in the involved limb are still present after patients return to sport.
Read more
Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction cutting, have been shown to be common mechanisms of injury for the ACL in field sports . Returning to multidirectional sports requires a proficiency and efficiency of movement when carrying out these tasks. There is a lack of standardized, objective criteria to accurately assess an athlete's ability to safely RTS. Therefore, there is a need for research that simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular strength/power deficits that may explain poor outcomes following ACLR. This study aims to further investigate movement patterns, limb asymmetry and muscle strength deficit in patients post-surgery to identify risk factors for re-injury and criteria for RTS.
The purpose of this study was to:
- Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.
- To explore the association of those findings with those who re-injure, those who have persistent knee pain or with those who fail to return to sport.
- To compare the ACLR participants with age and gender matched healthy multidirectional athletes.
It is hypothesised that biomechanical analysis will identify clear risk factors for poor outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks will aid in the identification of athletes who are not yet ready to return to sport and will inform the clinician of what must be targeted in specific rehabilitation protocols before return to sport is considered.
Brief protocol
Participants will be recruited from patients who are scheduled to undergo anterior cruciate ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be recruited from local multidirectional teams. Participation will be voluntary and after obtaining informed consent patients will be asked to complete pre-operative questionnaires to ascertain injury information, and the function of their knee. During surgery the surgeon will fill out an intra-operative questionnaire. Items recorded will include graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.
Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while the healthy participants will be tested on one occasion. The 3D testing session will include capturing of jumping, landing, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the infrared cameras and tracked at 200 frames per second. Participants will make contact with a force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments. Participants will also perform a muscle strength test using equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be tested.
Participants will also be asked to fill out validated questionnaires to monitor self reported knee function, their confidence in their knee and also collect data on any continuing adverse symptoms such as locking, giving way, swelling or pain. Participants will also be asked if and when they return to sport. Questionnaires will be administered to participants at pre-op, 3, 6, 9, 12, 24 months, 5 and 10 years post operatively.
Read the detailed description
3D Biomechanical testing involves the following progressive neuromuscular challenge tests:
- Single leg countermovement jump - Vertical jump as high as possible off one leg.
- Single leg drop jump- Hop from a 20cm height onto one leg and jump as high as possible with as little time spent on the ground
- Double leg drop jump- Hop from a 30cm height onto one leg and jump as high as possible with as little time spent on the ground
- Hurdle hop - Lateral hop over a 15cm hurdle followed by a hop back to the starting position and a hold for 2sec
- Single Leg Hop for distance - maximal jump for horizontal distance on one leg while sticking the landing
- Pre-planned change of direction cut - Sprint for 5 metres, make a 90 degree change of direction pre-determined by the tester and sprint for a further five meters to the finish
- Indecision cut - Sprint for five meters then react to a light stimulus and make a 90 degree cut to the left or right for a further 1.5metres
Patient Registry
Patient data will be inputted into the Sports Surgery Clinic medical data management software. Captured data will include:
- Patient information - Date of Surgery, Surgeon, Side of ACLR, confirmative Magnetic Resonance Imaging
- Pre-Operative data collection
- Pre-Operative Questionnaire- Date of injury, Activity undertaking when injury occurred, level of sporting activity, Injury mechanism, limb dominance, previous ACL injury or surgery.
- Marx Activity Questionnaire.
- ACL return to sports after injury (RSI) questionnaire- measures the athlete's emotions, confidence in performance, and risk appraisal in relation to return to sport after an ACL injury.
- Intra-Op data collection
- Operative notes are recorded in theatre using a standardised in theatre questionnaire. This form was developed under consensus with all surgeons who complete ACL reconstructive surgery at the Sports Surgery Clinic. Included are graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.
- 6 Month and 9 months post op data collection
- Marx Activity Questionnaire
- ACL RSI
- International Knee Documentation Committee (IKDC) form- The IKDC subjective form is a reliable and valid measure to monitor symptoms and function in daily living activities in those with knee disorders.
- Cincinnati Questionnaire - a valid and reliable measure of patient reported outcome after ACL injury
- Sports Surgery Clinic return to performance questionnaire- asks whether the participant has returned to sport, have they injured the operated knee or contralateral knee and asks whether they still experience pain and rate that pain on a numerical rating scale.
- 3D test battery findings
- 12 and 24 months post op data collection
- Marx Activity Questionnaire
- ACL RSI
- IKDC
- Sports Surgery Clinic return to performance questionnaire
Quality assurance plan
- Weekly cross-checking will be undertaken by two members of staff to ensure data entered onto the registry is correct and contemporaneous.
- A six-monthly audit of the registry will be undertaken by external auditors.
Registry standard operating procedures
- Basic patient contact details are inputted by administration staff.
- Physiotherapists and biomechanists input physical examination findings on medical data software.
- Self-reported questionnaires are completed on site using a tablet device and uploaded automatically to the registry once the questionnaire is completed.
- During theatre, the surgeon fills out the standardised intra-operative form, which is uploaded to the registry following surgery.
- For analysis or auditing purposes, data is downloaded from the Sports Surgery Clinic medical data management software and placed into Microsoft excel. Patient names are de-identified.
Sample size
- Suggested sample size = 1000
- Sample size calculation was carried out based on current numbers presenting to the clinic. Clinical numbers indicate a re-rupture rate of either the ipsilateral or contralateral ACL of 5%.
- This study aims to recruit 1000 participants and follow them over 24 months. With a likely re-rupture rate of 5%- it is hypothesized that 50 re-ruptures will occur over the 24 month period. This is a conservative number allowing for dropouts, and a split between contralateral and ipsilateral ACL injuries, which will be analysed separately.
- It is also aimed to recruit 50 healthy volunteers from multidirectional field sports teams.
Plan for missing data
- Checklist to flag missing data at the end of every week
- Participants with missing data may be excluded from the data analysis.
Statistical analysis plan
- Variables of interest include kinematics, kinetics, power, and vertical ground-reaction force at the pelvis, hip, knee and ankle at specific time points during different jumping, landing and cutting manoeuvres.
- Differences between involved and uninvolved legs will be calculated, and used to assess for asymmetry. Two group comparisons will be conducted using the Student t test or Kruskal-Wallis test for normal and non-normally distributed variables, respectively.
- Multivariable logistic regression, using variables with P values of </=0.05 from 2-group comparisons (those who go on to suffer a 2nd ACL injury and those who don't), will be used to identify the most predictive variables of the second ACL injury.
- A multivariable logistic regression analysis will also be conducted to identify the most predictive variables of patient reported subjective knee function (IKDC) and pain.
- Associations between intra-operative findings and outcome measures of re-injury pain and return to sport will be explored, also using regression analysis.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- Anterior Cruciate Ligament Reconstruction
- Keywords
- Knee injuries, Rehabilitation, Return to sport, Biomechanics
- 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.
Anterior Cruciate Ligament ReconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction | Those who have undergone unilateral anterior cruciate ligament reconstructive surgery in the Sports Surgery Clinic. Receives: Procedure: Anterior Cruciate Ligament Reconstruction | |
| Control | Healthy volunteers with no previous knee injury, no current lower limb injuries and take part in regular multidirectional team sports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Performance- change in status
The Sports Surgery Clinic return to performance questionnaire asks whether the participant has returned to sport.
Measured: 6,9,12 and 24 months post operatively
Injured operated knee- change in status
Participants are asked have they injured their operated knee.
Measured: 6,9,12 and 24 months post operatively
Injured their contralateral knee- change in status
Participants are asked have they injured their operated knee.
Measured: 6,9,12 and 24 months post operatively
Change in pain experienced
Participants will be asked to rate their pain on a numerical rating scale, 0-10.
Measured: 6,9,12 and 24 months post operatively
Secondary outcomes (2)
Change in Kinetic and kinematic composite score of the lower limb, pelvis and trunk
Associations can be made between post surgical change in biomechanical variables exhibited on sports specific tasks and poor outcomes following ACLR.
Measured: At 6 and 9 months post surgery
Change in International Knee Documentation Committee (IKDC)
The IKDC subjective form is a reliable and valid measure to monitor symptoms and function in daily living activities in those with knee disorders (Higgins et al. 2007).
Measured: 3, 6, 9, 12 and 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dr Neil Welch ASCC
- Sponsor type
- University, hospital or other
- Collaborators
- Sports Surgery Clinic Research Foundation, Insight Centre for Data Analytics, Science Foundation Ireland, University of Roehampton, University of Melbourne, University College Cork, University of Leeds, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor-investigator, Dr Neil Welch ASCC, Sports Surgery Clinic, Santry, Dublin
- Investigators
- Ray Moran, MCh (Orth) FRCSI FFSEM, Study director, Sports Surgery ClinicMark Jackson, MBBS BSc FRCS, Study director, Sports Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771548
- Sponsor's protocol ID
- SSC-ACL-001
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2016
- Last updated
- 22 Apr 2024
- Results posted
- No
Publications
Boden BP, Griffin LY, Garrett WE Jr. Etiology and Prevention of Noncontact ACL Injury. Phys Sportsmed. 2000 Apr;28(4):53-60. doi: 10.3810/psm.2000.04.841.
PubMed 20086634Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1.
PubMed 20595545Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
PubMed 17888709Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601.
PubMed 11292048Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
PubMed 19083699Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16. doi: 10.1177/03635465990270040201.
PubMed 10424208Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.
PubMed 20702858McAleese T, Welch N, King E, Roshan D, Keane N, Moran KA, Jackson M, Withers D, Moran R, Devitt BM. Primary Anterior Cruciate Ligament Reconstruction in Level 1 Athletes: Factors Associated With Return to Play, Reinjury, and Knee Function at 5 Years of Follow-up. Am J Sports Med. 2025 Mar;53(4):777-790. doi: 10.1177/03635465241313386. Epub 2025 Feb 7.
PubMed 39919304King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Biomechanical but Not Strength or Performance Measures Differentiate Male Athletes Who Experience ACL Reinjury on Return to Level 1 Sports. Am J Sports Med. 2021 Mar;49(4):918-927. doi: 10.1177/0363546520988018. Epub 2021 Feb 22.
PubMed 33617291King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Can Biomechanical Testing After Anterior Cruciate Ligament Reconstruction Identify Athletes at Risk for Subsequent ACL Injury to the Contralateral Uninjured Limb? Am J Sports Med. 2021 Mar;49(3):609-619. doi: 10.1177/0363546520985283. Epub 2021 Feb 9.
PubMed 33560866King E, Richter C, Jackson M, Franklyn-Miller A, Falvey E, Myer GD, Strike S, Withers D, Moran R. Factors Influencing Return to Play and Second Anterior Cruciate Ligament Injury Rates in Level 1 Athletes After Primary Anterior Cruciate Ligament Reconstruction: 2-Year Follow-up on 1432 Reconstructions at a Single Center. Am J Sports Med. 2020 Mar;48(4):812-824. doi: 10.1177/0363546519900170. Epub 2020 Feb 7.
PubMed 32031870King E, Richter C, Franklyn-Miller A, Wadey R, Moran R, Strike S. Back to Normal Symmetry? Biomechanical Variables Remain More Asymmetrical Than Normal During Jump and Change-of-Direction Testing 9 Months After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Apr;47(5):1175-1185. doi: 10.1177/0363546519830656.
PubMed 30943079
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis of Dynamic Tasks and Muscular Strength Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02771548
- Acronym / sponsor ID
- SSC-ACL-001
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Knee injuries, Rehabilitation, Return to sport, Biomechanics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dr Neil Welch ASCCUniversity, hospital or other
- Collaborators
- Sports Surgery Clinic Research Foundation, Insight Centre for Data Analytics, Science Foundation Ireland, University of Roehampton, University of Melbourne, University College Cork, University of Leeds, Children's Hospital Medical Center, Cincinnati
- Study start
- Jan 2014
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 13 May 2016 (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.
Background
Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an attempt to increase joint stability and facilitate athletes to return to sport (RTS). Although ACLR is considered a relatively successful procedure, dynamic control risk factors and strength and power deficits in the involved limb are still present after patients return to sport.
Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction cutting, have been shown to be common mechanisms of injury for the ACL in field sports . Returning to multidirectional sports requires a proficiency and efficiency of movement when carrying out these tasks. There is a lack of standardized, objective criteria to accurately assess an athlete's ability to safely RTS. Therefore, there is a need for research that simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular strength/power deficits that may explain poor outcomes following ACLR. This study aims to further investigate movement patterns, limb asymmetry and muscle strength deficit in patients post-surgery to identify risk factors for re-injury and criteria for RTS.
The purpose of this study was to:
- Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.
- To explore the association of those findings with those who re-injure, those who have persistent knee pain or with those who fail to return to sport.
- To compare the ACLR participants with age and gender matched healthy multidirectional athletes.
It is hypothesised that biomechanical analysis will identify clear risk factors for poor outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks will aid in the identification of athletes who are not yet ready to return to sport and will inform the clinician of what must be targeted in specific rehabilitation protocols before return to sport is considered.
Brief protocol
Participants will be recruited from patients who are scheduled to undergo anterior cruciate ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be recruited from local multidirectional teams. Participation will be voluntary and after obtaining informed consent patients will be asked to complete pre-operative questionnaires to ascertain injury information, and the function of their knee. During surgery the surgeon will fill out an intra-operative questionnaire. Items recorded will include graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.
Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while the healthy participants will be tested on one occasion. The 3D testing session will include capturing of jumping, landing, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the infrared cameras and tracked at 200 frames per second. Participants will make contact with a force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments. Participants will also perform a muscle strength test using equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be tested.
Participants will also be asked to fill out validated questionnaires to monitor self reported knee function, their confidence in their knee and also collect data on any continuing adverse symptoms such as locking, giving way, swelling or pain. Participants will also be asked if and when they return to sport. Questionnaires will be administered to participants at pre-op, 3, 6, 9, 12, 24 months, 5 and 10 years post operatively.
Detailed description
3D Biomechanical testing involves the following progressive neuromuscular challenge tests:
- Single leg countermovement jump - Vertical jump as high as possible off one leg.
- Single leg drop jump- Hop from a 20cm height onto one leg and jump as high as possible with as little time spent on the ground
- Double leg drop jump- Hop from a 30cm height onto one leg and jump as high as possible with as little time spent on the ground
- Hurdle hop - Lateral hop over a 15cm hurdle followed by a hop back to the starting position and a hold for 2sec
- Single Leg Hop for distance - maximal jump for horizontal distance on one leg while sticking the landing
- Pre-planned change of direction cut - Sprint for 5 metres, make a 90 degree change of direction pre-determined by the tester and sprint for a further five meters to the finish
- Indecision cut - Sprint for five meters then react to a light stimulus and make a 90 degree cut to the left or right for a further 1.5metres
Patient Registry
Patient data will be inputted into the Sports Surgery Clinic medical data management software. Captured data will include:
- Patient information - Date of Surgery, Surgeon, Side of ACLR, confirmative Magnetic Resonance Imaging
- Pre-Operative data collection
- Pre-Operative Questionnaire- Date of injury, Activity undertaking when injury occurred, level of sporting activity, Injury mechanism, limb dominance, previous ACL injury or surgery.
- Marx Activity Questionnaire.
- ACL return to sports after injury (RSI) questionnaire- measures the athlete's emotions, confidence in performance, and risk appraisal in relation to return to sport after an ACL injury.
- Intra-Op data collection
- Operative notes are recorded in theatre using a standardised in theatre questionnaire. This form was developed under consensus with all surgeons who complete ACL reconstructive surgery at the Sports Surgery Clinic. Included are graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.
- 6 Month and 9 months post op data collection
- Marx Activity Questionnaire
- ACL RSI
- International Knee Documentation Committee (IKDC) form- The IKDC subjective form is a reliable and valid measure to monitor symptoms and function in daily living activities in those with knee disorders.
- Cincinnati Questionnaire - a valid and reliable measure of patient reported outcome after ACL injury
- Sports Surgery Clinic return to performance questionnaire- asks whether the participant has returned to sport, have they injured the operated knee or contralateral knee and asks whether they still experience pain and rate that pain on a numerical rating scale.
- 3D test battery findings
- 12 and 24 months post op data collection
- Marx Activity Questionnaire
- ACL RSI
- IKDC
- Sports Surgery Clinic return to performance questionnaire
Quality assurance plan
- Weekly cross-checking will be undertaken by two members of staff to ensure data entered onto the registry is correct and contemporaneous.
- A six-monthly audit of the registry will be undertaken by external auditors.
Registry standard operating procedures
- Basic patient contact details are inputted by administration staff.
- Physiotherapists and biomechanists input physical examination findings on medical data software.
- Self-reported questionnaires are completed on site using a tablet device and uploaded automatically to the registry once the questionnaire is completed.
- During theatre, the surgeon fills out the standardised intra-operative form, which is uploaded to the registry following surgery.
- For analysis or auditing purposes, data is downloaded from the Sports Surgery Clinic medical data management software and placed into Microsoft excel. Patient names are de-identified.
Sample size
- Suggested sample size = 1000
- Sample size calculation was carried out based on current numbers presenting to the clinic. Clinical numbers indicate a re-rupture rate of either the ipsilateral or contralateral ACL of 5%.
- This study aims to recruit 1000 participants and follow them over 24 months. With a likely re-rupture rate of 5%- it is hypothesized that 50 re-ruptures will occur over the 24 month period. This is a conservative number allowing for dropouts, and a split between contralateral and ipsilateral ACL injuries, which will be analysed separately.
- It is also aimed to recruit 50 healthy volunteers from multidirectional field sports teams.
Plan for missing data
- Checklist to flag missing data at the end of every week
- Participants with missing data may be excluded from the data analysis.
Statistical analysis plan
- Variables of interest include kinematics, kinetics, power, and vertical ground-reaction force at the pelvis, hip, knee and ankle at specific time points during different jumping, landing and cutting manoeuvres.
- Differences between involved and uninvolved legs will be calculated, and used to assess for asymmetry. Two group comparisons will be conducted using the Student t test or Kruskal-Wallis test for normal and non-normally distributed variables, respectively.
- Multivariable logistic regression, using variables with P values of </=0.05 from 2-group comparisons (those who go on to suffer a 2nd ACL injury and those who don't), will be used to identify the most predictive variables of the second ACL injury.
- A multivariable logistic regression analysis will also be conducted to identify the most predictive variables of patient reported subjective knee function (IKDC) and pain.
- Associations between intra-operative findings and outcome measures of re-injury pain and return to sport will be explored, also using regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction | – | Procedure: Anterior Cruciate Ligament ReconstructionThose who have undergone unilateral anterior cruciate ligament reconstructive surgery in the Sports Surgery Clinic. |
| Control | – | –Healthy volunteers with no previous knee injury, no current lower limb injuries and take part in regular multidirectional team sports. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Those who undergo anterior cruciate ligament reconstruction in the Sports Surgery Clinic, Dublin, and who meet the inclusion criteria, will be asked if they wish to participate in this study. Sports Surgery Clinic is a private hospital where over 750 ACL reconstructive surgeries take place each year. Many patients will travel from all over the country of Ireland to the clinic for the surgery, meaning there is a wide catchment area for participants.
Key inclusion criteria (3 listed)
- Active participants
- Anterior cruciate ligament reconstruction surgery in the Sports Surgery Clinic.
- Over the age of 13 years
Key exclusion criteria (2 listed)
- Multiple orthopaedic injuries concurrently.
- Surgery outside of Sports Surgery Clinic.
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 |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction | Procedure or surgery | Anterior Cruciate Ligament Reconstruction |
Primary outcome
Return to Performance- change in status
Time frame: 6,9,12 and 24 months post operatively
The Sports Surgery Clinic return to performance questionnaire asks whether the participant has returned to sport.
Injured operated knee- change in status
Time frame: 6,9,12 and 24 months post operatively
Participants are asked have they injured their operated knee.
Injured their contralateral knee- change in status
Time frame: 6,9,12 and 24 months post operatively
Participants are asked have they injured their operated knee.
Change in pain experienced
Time frame: 6,9,12 and 24 months post operatively
Participants will be asked to rate their pain on a numerical rating scale, 0-10.
2 secondary outcomes
Change in Kinetic and kinematic composite score of the lower limb, pelvis and trunk
Time frame: At 6 and 9 months post surgery
Change in International Knee Documentation Committee (IKDC)
Time frame: 3, 6, 9, 12 and 24 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 20086634Boden BP, Griffin LY, Garrett WE Jr. Etiology and Prevention of Noncontact ACL Injury. Phys Sportsmed. 2000 Apr;28(4):53-60. doi: 10.3810/psm.2000.04.841.
- Background: PubMed 20595545Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1.
- Background: PubMed 17888709Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
- Background: PubMed 11292048Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601.
- Background: PubMed 19083699Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
- Background: PubMed 10424208Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16. doi: 10.1177/03635465990270040201.
- Background: PubMed 20702858Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.
- Derived from this study: PubMed 39919304McAleese T, Welch N, King E, Roshan D, Keane N, Moran KA, Jackson M, Withers D, Moran R, Devitt BM. Primary Anterior Cruciate Ligament Reconstruction in Level 1 Athletes: Factors Associated With Return to Play, Reinjury, and Knee Function at 5 Years of Follow-up. Am J Sports Med. 2025 Mar;53(4):777-790. doi: 10.1177/03635465241313386. Epub 2025 Feb 7.
- Derived from this study: PubMed 33617291King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Biomechanical but Not Strength or Performance Measures Differentiate Male Athletes Who Experience ACL Reinjury on Return to Level 1 Sports. Am J Sports Med. 2021 Mar;49(4):918-927. doi: 10.1177/0363546520988018. Epub 2021 Feb 22.
- Derived from this study: PubMed 33560866King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Can Biomechanical Testing After Anterior Cruciate Ligament Reconstruction Identify Athletes at Risk for Subsequent ACL Injury to the Contralateral Uninjured Limb? Am J Sports Med. 2021 Mar;49(3):609-619. doi: 10.1177/0363546520985283. Epub 2021 Feb 9.
- Derived from this study: PubMed 32031870King E, Richter C, Jackson M, Franklyn-Miller A, Falvey E, Myer GD, Strike S, Withers D, Moran R. Factors Influencing Return to Play and Second Anterior Cruciate Ligament Injury Rates in Level 1 Athletes After Primary Anterior Cruciate Ligament Reconstruction: 2-Year Follow-up on 1432 Reconstructions at a Single Center. Am J Sports Med. 2020 Mar;48(4):812-824. doi: 10.1177/0363546519900170. Epub 2020 Feb 7.
- Derived from this study: PubMed 30943079King E, Richter C, Franklyn-Miller A, Wadey R, Moran R, Strike S. Back to Normal Symmetry? Biomechanical Variables Remain More Asymmetrical Than Normal During Jump and Change-of-Direction Testing 9 Months After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Apr;47(5):1175-1185. doi: 10.1177/0363546519830656.
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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.
Ray Moran, MCh (Orth) FRCSI FFSEM study director
Sports Surgery Clinic
Mark Jackson, MBBS BSc FRCS study director
Sports Surgery Clinic
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 Rupture of Anterior Cruciate Ligament, run by Dr Neil Welch ASCC at 1 site in Ireland.
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 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: looking for participants now, as of the sponsor's last update on 22 Apr 2024. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil B Welch, PhD (00 353 1 526 2030, welchn2@upmc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Performance- change in status (time frame: 6,9,12 and 24 months post operatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771548, which also lists 12 linked publications.
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 22 Apr 2024.