Ligament; Laxity, KneeNCT02173483
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial
A study testing Quadriceps graft in people with Ligament; Laxity, Knee and Rupture of Anterior Cruciate Ligament, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ligament; Laxity, Knee, Rupture of Anterior Cruciate Ligament
- What is being tested?
- Quadriceps graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jan 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior cruciate ligament rupture
Who cannot join
- current malignant disease
- Rheumatoid arthritis
- Other knee ligament instability
- Obesity BMI >30
- Morbus Bechterew
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial
The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.
- Being tested
- Quadriceps graft
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps graftProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps graft | Other | Proximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture. Receives: Procedure: Quadriceps graft |
| Hamstrings Graft | Other | The Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture. Receives: Procedure: Quadriceps graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome score - IKDC
IKDC (international Knee Documentation committee) subjective score (0-100)
Measured: 12 month
Secondary outcomes (5)
Knee laxity
KT-1000 arthrometer
Measured: 12 month
Patient reported outcome score - KOOS
Koos (Knee injury and Osteoarthritis Outcome Score) contains 5 subscores (Pain, ADL, QOL, Symptoms, Sport \& recreation). Each subscore ranges from 0-100 where higher values represent a better score.
Measured: 12 month
TEGNER
Patient reported outcome score (range 0-10)
Measured: 12 month
Anterior knee pain scale
Patient reported outcome score (range 0-100)
Measured: 12 month
Donor Site morbidity score
Patient reported outcome score (range 100-0)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ligament; Laxity, KneeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173483
- Sponsor's protocol ID
- Danish EC - 110728514
- Status last verified
- Apr 2019
- First submitted
- 17 Jun 2014
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sinding KS, Nielsen TG, Hvid LG, Lind M, Dalgas U. Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Sports Med. 2020 Jul;50(7):1393-1403. doi: 10.1007/s40279-020-01276-x.
PubMed 32125668Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8.
PubMed 31704697
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02173483
- Acronym / sponsor ID
- Danish EC - 110728514
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Jun 2014 (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 study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadriceps graft | Other | Procedure: Quadriceps graftProximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture. |
| Hamstrings Graft | Other | Procedure: Quadriceps graftThe Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anterior cruciate ligament rupture
Key exclusion criteria (5 listed)
- current malignant disease
- Rheumatoid arthritis
- Other knee ligament instability
- Obesity BMI >30
- Morbus Bechterew
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 |
|---|---|---|
| Quadriceps graft | Procedure or surgery | Hamstrings Graft, Quadriceps graft |
Primary outcome
Patient reported outcome score - IKDC
Time frame: 12 month
IKDC (international Knee Documentation committee) subjective score (0-100)
5 secondary outcomes
Knee laxity
Time frame: 12 month
Patient reported outcome score - KOOS
Time frame: 12 month
TEGNER
Time frame: 12 month
Anterior knee pain scale
Time frame: 12 month
Donor Site morbidity score
Time frame: 12 month
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 29 Apr 2019.
- Derived from this study: PubMed 32125668Sinding KS, Nielsen TG, Hvid LG, Lind M, Dalgas U. Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Sports Med. 2020 Jul;50(7):1393-1403. doi: 10.1007/s40279-020-01276-x.
- Derived from this study: PubMed 31704697Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps graft in people with Ligament; Laxity, Knee and Rupture of Anterior Cruciate Ligament, run by Aarhus University Hospital at 1 site in Denmark.
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 5 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 29 Apr 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 Denmark. 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?
Patient reported outcome score - IKDC (time frame: 12 month). 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 NCT02173483, which also lists 2 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 29 Apr 2019.