Anterior Cruciate Ligament Injury1vs2hamNCT03626883
Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction
A study testing single-bundle, single-hamstring ACL reconstruction and single-bundle, double-hamstring ACL reconstruction in people with Anterior Cruciate Ligament Injury, run by Rafał Kamiński at 1 site in Poland.
Trial summary
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- single-bundle, single-hamstring ACL reconstruction and single-bundle, double-hamstring ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2015to 30 Jul 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
Who cannot join
- revision anterior cruciate ligament surgery
- other lower limb injuries
Trial locations and contacts
1 site in 1 country.
Poland1 site
Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
Otwock, Woj. Mazowieckie, 05-400
About this study
Official title: Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.
Read the detailed description
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.
The study will recruit 60 patients per each of two arms.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- single-bundle, single-hamstring ACL reconstruction, single-bundle, double-hamstring ACL reconstruction
- Keywords
- arthroscopy
- 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.
single-bundle, single-hamstring ACL reconstructionProcedure or surgery
anterior cruciate ligament reconstruction with single hamstring tendon
single-bundle, double-hamstring ACL reconstructionProcedure or surgery
anterior cruciate ligament reconstruction with 2 hamstring tendons
| Study group | Role | What they receive |
|---|---|---|
| 1 hamstring | Experimental | Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'. Receives: Procedure: single-bundle, single-hamstring ACL reconstruction |
| 2 hamstrings | Active comparator | Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'. Receives: Procedure: single-bundle, double-hamstring ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Measured: up to 5yrs
Secondary outcomes (7)
Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks
Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery.
Baltimore: Williams \& Wilkins; 1994. p. 275-96.
Measured: up to 5yrs
Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs
Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 Baltimore: Williams \& Wilkins; 1994. p. 275-96.
Measured: up to 5yrs
Change from baseline Lysholm Knee Questionnaire at 104 weeks
Knee function questionnaire (patient-administered), minimum score: 0, maximum score: 100. Full description in: Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982; 10:150-4. [PubMed: 6896798]
Measured: up to 5yrs
Change from baseline Visual Analog Scale for Pain at 104 weeks
Separate Outcome Measure, with minimum 0 and maximum of 10. Full description in: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi:10.1002/acr.20543.
Measured: up to 5yrs
Change from baseline tunnel volume at 104 weeks
Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively
Measured: 104-weeks postop
Change from baseline tunnel diameter at 104 weeks
Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively
Measured: 104-weeks postop
Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks
The medical records will be prospectively abstracted and analyzed for any arthrocentesis, revision surgery or additional procedures performed in the study group up top 104 weeks after index surgery.
Measured: up to 5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Dec 2015
- Primary completion30 Jan 2020
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafał Kamiński
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Marcin K Wasko, M.D., Ph.D., Principal investigator, Centre for Postgraduate Medical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626883
- Sponsor's protocol ID
- 1vs2 ham
- Acronym
- 1vs2ham
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2018
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kulinski K, Wasko MK, Trams E, Malesa K, Pomianowski S, Kaminski R. Anterior Cruciate Ligament Reconstruction Using a 4-Strand Semitendinosus Tendon Graft or a Doubled Semitendinosus and Gracilis Tendon Graft: A 4.5-Year Prospective, Randomized, Double-Blind, Parallel-Group Study. Am J Sports Med. 2023 Mar;51(3):615-626. doi: 10.1177/03635465221149738.
PubMed 36856280
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT03626883
- Acronym / sponsor ID
- 1vs2ham / 1vs2 ham
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rafał KamińskiUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 13 Aug 2018 (actual)
- 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 aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.
Detailed description
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.
The study will recruit 60 patients per each of two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 hamstring | Experimental | Procedure: single-bundle, single-hamstring ACL reconstructionPatients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'. |
| 2 hamstrings | Active comparator | Procedure: single-bundle, double-hamstring ACL reconstructionPatients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
Key exclusion criteria (2 listed)
- revision anterior cruciate ligament surgery
- other lower limb injuries
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, single-hamstring ACL reconstructionanterior cruciate ligament reconstruction with single hamstring tendon | Procedure or surgery | 1 hamstring |
| single-bundle, double-hamstring ACL reconstructionanterior cruciate ligament reconstruction with 2 hamstring tendons | Procedure or surgery | 2 hamstrings |
Primary outcome
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Time frame: up to 5yrs
7 secondary outcomes
Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks
Time frame: up to 5yrs
Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs
Time frame: up to 5yrs
Change from baseline Lysholm Knee Questionnaire at 104 weeks
Time frame: up to 5yrs
Change from baseline Visual Analog Scale for Pain at 104 weeks
Time frame: up to 5yrs
Change from baseline tunnel volume at 104 weeks
Time frame: 104-weeks postop
Change from baseline tunnel diameter at 104 weeks
Time frame: 104-weeks postop
Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks
Time frame: up to 5yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 36856280Kulinski K, Wasko MK, Trams E, Malesa K, Pomianowski S, Kaminski R. Anterior Cruciate Ligament Reconstruction Using a 4-Strand Semitendinosus Tendon Graft or a Doubled Semitendinosus and Gracilis Tendon Graft: A 4.5-Year Prospective, Randomized, Double-Blind, Parallel-Group Study. Am J Sports Med. 2023 Mar;51(3):615-626. doi: 10.1177/03635465221149738.
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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.
Marcin K Wasko, M.D., Ph.D. principal investigator
Centre for Postgraduate Medical Education in Warsaw
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, single-hamstring ACL reconstruction and single-bundle, double-hamstring ACL reconstruction in people with Anterior Cruciate Ligament Injury, run by Rafał Kamiński at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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 Poland. 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?
Results are not available in the source record.
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?
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points (time frame: up to 5yrs). 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 NCT03626883, which also lists 1 linked publication.
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 21 Feb 2022.