Anterior Cruciate Ligament InjuriesPhase 1/2NCT04123834
Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
A Phase 1/2 study testing Patella tendon & bone block autograft + press-fit femoral technique, Arthroscopic ACL reconstruction and Hamstring tendon autograft + implant fixation in people with Anterior Cruciate Ligament Injuries and Ligament; Rupture, Knee, Spontaneous, run by Universitas Indonesia.
Trial summary
The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
- What is being tested?
- Patella tendon & bone block autograft + press-fit femoral technique, Arthroscopic ACL reconstruction and Hamstring tendon autograft + implant fixation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 30 Mar 2014
- Phase
- Phase 1/2
- 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
Who may be able to join
- total rupture of ACL on a single knee
Who cannot join
- increased knee laxity according to Beighton Hypermobility Score
- previous history of knee surgery
About this study
Official title: Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autografts Using Press-Fit Fixation Technique and Hamstring Autografts Using Implant in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective Study
The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.
Read the detailed description
Purpose: The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.
Materials and Methods: A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.
- Conditions
- Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
- Being tested
- Patella tendon & bone block autograft + press-fit femoral technique, Arthroscopic ACL reconstruction, Hamstring tendon autograft + implant fixation
- Keywords
- anterior cruciate ligament, anterior cruciate ligament injury, implantless ACL reconstruction, press-fit fixation
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patella tendon & bone block autograft + press-fit femoral techniqueProcedure or surgery
Implantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture.
Arthroscopic ACL reconstructionProcedure or surgery
Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
Hamstring tendon autograft + implant fixationDevice
Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
| Study group | Role | What they receive |
|---|---|---|
| implantless Arthroscopic ACL reconstruction | Experimental | implantless Arthroscopic ACL reconstruction using press-fit femoral technique Receives: Procedure: Patella tendon & bone block autograft + press-fit femoral technique; Procedure: Arthroscopic ACL reconstruction |
| Arthroscopic ACL reconstruction with implant | Experimental | ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button) Receives: Procedure: Arthroscopic ACL reconstruction; Device: Hamstring tendon autograft + implant fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior knee laxity
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Measured: At 1 month after surgery.
Anterior knee laxity
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Measured: At 3 months after surgery.
Anterior knee laxity
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Measured: At 6 months after surgery.
Functional outcome score International Knee Documentation committee (IKDC)
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities.
Number of items: 18 subscales:
- symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee.
- sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping
- function and activity of daily living: knee condition prior to injury
Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Measured: At 1 month after surgery.
Functional outcome score International Knee Documentation committee (IKDC)
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities.
Number of items: 18 subscales:
- symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee.
- sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping
- function and activity of daily living: knee condition prior to injury
Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Measured: At 3 months after surgery.
Functional outcome score International Knee Documentation committee (IKDC)
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities.
Number of items: 18 subscales:
- symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee.
- sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping
- function and activity of daily living: knee condition prior to injury
Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Measured: At 6 months after surgery.
Functional outcome score Tegner-Lysholm
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life.
Number of items: 8 items, each scored differently
Subscales:
- limp (0, 3, 5)
- support (0, 2, 5)
- locking (0, 2, 6, 10, 15)
- instability (0, 5, 10, 15, 20, 25)
- pain (0, 5, 10, 15, 20, 25)
- swelling (0, 2, 6, 10)
- stair climbing (0, 2, 6, 10)
- squatting (0, 2, 4, 5)
Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Measured: At 1 month after surgery.
Functional outcome scores Tegner-Lysholm
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life.
Number of items: 8 items, each scored differently
Subscales:
- limp (0, 3, 5)
- support (0, 2, 5)
- locking (0, 2, 6, 10, 15)
- instability (0, 5, 10, 15, 20, 25)
- pain (0, 5, 10, 15, 20, 25)
- swelling (0, 2, 6, 10)
- stair climbing (0, 2, 6, 10)
- squatting (0, 2, 4, 5)
Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Measured: At 3 months after surgery.
Functional outcome scores Tegner-Lysholm
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life.
Number of items: 8 items, each scored differently
Subscales:
- limp (0, 3, 5)
- support (0, 2, 5)
- locking (0, 2, 6, 10, 15)
- instability (0, 5, 10, 15, 20, 25)
- pain (0, 5, 10, 15, 20, 25)
- swelling (0, 2, 6, 10)
- stair climbing (0, 2, 6, 10)
- squatting (0, 2, 4, 5)
Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Measured: At 6 months after surgery.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades).
Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales:
- pain frequency and severity during functional activities (subscale score range: 0-36)
- symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28)
- difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68)
- difficulty experienced with sport and recreational activities (subscale score range: 0-20)
- knee-related quality of life (QOL) (subscale score range: 0-16)
The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
Measured: At 1 month after surgery.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades).
Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales:
- pain frequency and severity during functional activities (subscale score range: 0-36)
- symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28)
- difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68)
- difficulty experienced with sport and recreational activities (subscale score range: 0-20)
- knee-related quality of life (QOL) (subscale score range: 0-16)
The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
Measured: At 3 months after surgery.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades).
Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales:
- pain frequency and severity during functional activities (subscale score range: 0-36)
- symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28)
- difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68)
- difficulty experienced with sport and recreational activities (subscale score range: 0-20)
- knee-related quality of life (QOL) (subscale score range: 0-16)
The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
Measured: At 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Mar 2013
- Primary completion30 Mar 2014
- Study completion30 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andri Maruli Tua Lubis, Universitas Indonesia
- Investigators
- Andri MT Lubis, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123834
- Sponsor's protocol ID
- Press-Fit ACL
- Status last verified
- Oct 2019
- First submitted
- 29 Sep 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biau DJ, Tournoux C, Katsahian S, Schranz PJ, Nizard RS. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006 Apr 29;332(7548):995-1001. doi: 10.1136/bmj.38784.384109.2F. Epub 2006 Apr 7.
PubMed 16603564Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
PubMed 20660401Romanini E, D'Angelo F, De Masi S, Adriani E, Magaletti M, Lacorte E, Laricchiuta P, Sagliocca L, Morciano C, Mele A. Graft selection in arthroscopic anterior cruciate ligament reconstruction. J Orthop Traumatol. 2010 Dec;11(4):211-9. doi: 10.1007/s10195-010-0124-9. Epub 2010 Dec 23.
PubMed 21181226Remer EM, Fitzgerald SW, Friedman H, Rogers LF, Hendrix RW, Schafer MF. Anterior cruciate ligament injury: MR imaging diagnosis and patterns of injury. Radiographics. 1992 Sep;12(5):901-15. doi: 10.1148/radiographics.12.5.1529133.
PubMed 1529133Tirmik U, Mahirogullari M, Kuskucu M. The results of reconstruction of the ACL using the cross-pin femoral system and four-strand hamstring tendon autografts. Acta Orthop Traumatol Turc. 2011;45(4):233-9. doi: 10.3944/AOTT.2011.2309.
PubMed 21908962Mei Y, Ao YF, Wang JQ, Ma Y, Zhang X, Wang JN, Zhu JX. Clinical characteristics of 4355 patients with anterior cruciate ligament injury. Chin Med J (Engl). 2013 Dec;126(23):4487-92.
PubMed 24286412Taketomi S, Inui H, Yamagami R, Shirakawa N, Kawaguchi K, Nakagawa T, Tanaka S. Bone-Patellar Tendon-Bone Autograft versus Hamstring Tendon Autograft for Anatomical Anterior Cruciate Ligament Reconstruction with Three-Dimensional Validation of Femoral and Tibial Tunnel Positions. J Knee Surg. 2018 Oct;31(9):866-874. doi: 10.1055/s-0037-1615813. Epub 2017 Dec 28.
PubMed 29284176Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.
PubMed 16210575Noyes FR, Barber-Westin SD. Treatment of meniscus tears during anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jan;28(1):123-30. doi: 10.1016/j.arthro.2011.08.292. Epub 2011 Nov 9.
PubMed 22074619Widuchowski W, Widuchowska M, Koczy B, Dragan S, Czamara A, Tomaszewski W, Widuchowski J. Femoral press-fit fixation in ACL reconstruction using bone-patellar tendon-bone autograft: results at 15 years follow-up. BMC Musculoskelet Disord. 2012 Jun 27;13:115. doi: 10.1186/1471-2474-13-115.
PubMed 22738187Wipfler B, Donner S, Zechmann CM, Springer J, Siebold R, Paessler HH. Anterior cruciate ligament reconstruction using patellar tendon versus hamstring tendon: a prospective comparative study with 9-year follow-up. Arthroscopy. 2011 May;27(5):653-65. doi: 10.1016/j.arthro.2011.01.015.
PubMed 21663722
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autografts Using Press-Fit Fixation Technique and Hamstring Autografts Using Implant in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective Study
- ClinicalTrials.gov ID
- NCT04123834
- Acronym / sponsor ID
- Press-Fit ACL
- Conditions
- Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
- Keywords
- anterior cruciate ligament, anterior cruciate ligament injury, implantless ACL reconstruction, press-fit fixation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 30 Mar 2014 (actual)
- Study completion
- 30 Mar 2014 (actual)
- First posted
- 11 Oct 2019 (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 use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.
Detailed description
Purpose: The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.
Materials and Methods: A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.
| Arm | Type | Receives |
|---|---|---|
| implantless Arthroscopic ACL reconstruction | Experimental | Procedure: Patella tendon & bone block autograft + press-fit femoral technique, Procedure: Arthroscopic ACL reconstructionimplantless Arthroscopic ACL reconstruction using press-fit femoral technique |
| Arthroscopic ACL reconstruction with implant | Experimental | Procedure: Arthroscopic ACL reconstruction, Device: Hamstring tendon autograft + implant fixationACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- total rupture of ACL on a single knee
Key exclusion criteria (2 listed)
- increased knee laxity according to Beighton Hypermobility Score
- previous history of knee surgery
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 |
|---|---|---|
| Patella tendon & bone block autograft + press-fit femoral techniqueImplantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture. | Procedure or surgery | implantless Arthroscopic ACL reconstruction |
| Arthroscopic ACL reconstructionArthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button) | Procedure or surgery | Arthroscopic ACL reconstruction with implant, implantless Arthroscopic ACL reconstruction |
| Hamstring tendon autograft + implant fixationArthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button) | Device | Arthroscopic ACL reconstruction with implant |
Primary outcome
Anterior knee laxity
Time frame: At 1 month after surgery.
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Anterior knee laxity
Time frame: At 3 months after surgery.
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Anterior knee laxity
Time frame: At 6 months after surgery.
Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Functional outcome score International Knee Documentation committee (IKDC)
Time frame: At 1 month after surgery.
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities. Number of items: 18 subscales: * symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee. * sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping * function and activity of daily living: knee condition prior to injury Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Functional outcome score International Knee Documentation committee (IKDC)
Time frame: At 3 months after surgery.
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities. Number of items: 18 subscales: * symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee. * sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping * function and activity of daily living: knee condition prior to injury Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Functional outcome score International Knee Documentation committee (IKDC)
Time frame: At 6 months after surgery.
International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities. Number of items: 18 subscales: * symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee. * sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping * function and activity of daily living: knee condition prior to injury Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Functional outcome score Tegner-Lysholm
Time frame: At 1 month after surgery.
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life. Number of items: 8 items, each scored differently Subscales: 1. limp (0, 3, 5) 2. support (0, 2, 5) 3. locking (0, 2, 6, 10, 15) 4. instability (0, 5, 10, 15, 20, 25) 5. pain (0, 5, 10, 15, 20, 25) 6. swelling (0, 2, 6, 10) 7. stair climbing (0, 2, 6, 10) 8. squatting (0, 2, 4, 5) Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Functional outcome scores Tegner-Lysholm
Time frame: At 3 months after surgery.
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life. Number of items: 8 items, each scored differently Subscales: 1. limp (0, 3, 5) 2. support (0, 2, 5) 3. locking (0, 2, 6, 10, 15) 4. instability (0, 5, 10, 15, 20, 25) 5. pain (0, 5, 10, 15, 20, 25) 6. swelling (0, 2, 6, 10) 7. stair climbing (0, 2, 6, 10) 8. squatting (0, 2, 4, 5) Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Functional outcome scores Tegner-Lysholm
Time frame: At 6 months after surgery.
Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life. Number of items: 8 items, each scored differently Subscales: 1. limp (0, 3, 5) 2. support (0, 2, 5) 3. locking (0, 2, 6, 10, 15) 4. instability (0, 5, 10, 15, 20, 25) 5. pain (0, 5, 10, 15, 20, 25) 6. swelling (0, 2, 6, 10) 7. stair climbing (0, 2, 6, 10) 8. squatting (0, 2, 4, 5) Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Time frame: At 1 month after surgery.
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades). Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales: * pain frequency and severity during functional activities (subscale score range: 0-36) * symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28) * difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68) * difficulty experienced with sport and recreational activities (subscale score range: 0-20) * knee-related quality of life (QOL) (subscale score range: 0-16) The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Time frame: At 3 months after surgery.
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades). Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales: * pain frequency and severity during functional activities (subscale score range: 0-36) * symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28) * difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68) * difficulty experienced with sport and recreational activities (subscale score range: 0-20) * knee-related quality of life (QOL) (subscale score range: 0-16) The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Time frame: At 6 months after surgery.
Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades). Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales: * pain frequency and severity during functional activities (subscale score range: 0-36) * symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28) * difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68) * difficulty experienced with sport and recreational activities (subscale score range: 0-20) * knee-related quality of life (QOL) (subscale score range: 0-16) The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.
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 11 Oct 2019.
- Background: PubMed 16603564Biau DJ, Tournoux C, Katsahian S, Schranz PJ, Nizard RS. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006 Apr 29;332(7548):995-1001. doi: 10.1136/bmj.38784.384109.2F. Epub 2006 Apr 7.
- Background: PubMed 20660401Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
- Background: PubMed 21181226Romanini E, D'Angelo F, De Masi S, Adriani E, Magaletti M, Lacorte E, Laricchiuta P, Sagliocca L, Morciano C, Mele A. Graft selection in arthroscopic anterior cruciate ligament reconstruction. J Orthop Traumatol. 2010 Dec;11(4):211-9. doi: 10.1007/s10195-010-0124-9. Epub 2010 Dec 23.
- Background: PubMed 1529133Remer EM, Fitzgerald SW, Friedman H, Rogers LF, Hendrix RW, Schafer MF. Anterior cruciate ligament injury: MR imaging diagnosis and patterns of injury. Radiographics. 1992 Sep;12(5):901-15. doi: 10.1148/radiographics.12.5.1529133.
- Background: PubMed 21908962Tirmik U, Mahirogullari M, Kuskucu M. The results of reconstruction of the ACL using the cross-pin femoral system and four-strand hamstring tendon autografts. Acta Orthop Traumatol Turc. 2011;45(4):233-9. doi: 10.3944/AOTT.2011.2309.
- Background: PubMed 24286412Mei Y, Ao YF, Wang JQ, Ma Y, Zhang X, Wang JN, Zhu JX. Clinical characteristics of 4355 patients with anterior cruciate ligament injury. Chin Med J (Engl). 2013 Dec;126(23):4487-92.
- Background: PubMed 29284176Taketomi S, Inui H, Yamagami R, Shirakawa N, Kawaguchi K, Nakagawa T, Tanaka S. Bone-Patellar Tendon-Bone Autograft versus Hamstring Tendon Autograft for Anatomical Anterior Cruciate Ligament Reconstruction with Three-Dimensional Validation of Femoral and Tibial Tunnel Positions. J Knee Surg. 2018 Oct;31(9):866-874. doi: 10.1055/s-0037-1615813. Epub 2017 Dec 28.
- Background: PubMed 16210575Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.
- Background: PubMed 22074619Noyes FR, Barber-Westin SD. Treatment of meniscus tears during anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jan;28(1):123-30. doi: 10.1016/j.arthro.2011.08.292. Epub 2011 Nov 9.
- Background: PubMed 22738187Widuchowski W, Widuchowska M, Koczy B, Dragan S, Czamara A, Tomaszewski W, Widuchowski J. Femoral press-fit fixation in ACL reconstruction using bone-patellar tendon-bone autograft: results at 15 years follow-up. BMC Musculoskelet Disord. 2012 Jun 27;13:115. doi: 10.1186/1471-2474-13-115.
- Background: PubMed 21663722Wipfler B, Donner S, Zechmann CM, Springer J, Siebold R, Paessler HH. Anterior cruciate ligament reconstruction using patellar tendon versus hamstring tendon: a prospective comparative study with 9-year follow-up. Arthroscopy. 2011 May;27(5):653-65. doi: 10.1016/j.arthro.2011.01.015.
- Individual participant dataSharing planned: No
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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.
Andri MT Lubis, MD, PhD principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Patella tendon & bone block autograft + press-fit femoral technique, Arthroscopic ACL reconstruction and Hamstring tendon autograft + implant fixation in people with Anterior Cruciate Ligament Injuries and Ligament; Rupture, Knee, Spontaneous, run by Universitas Indonesia.
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: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anterior knee laxity (time frame: At 1 month after surgery.). The study lists 12 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 NCT04123834, which also lists 11 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 11 Oct 2019.