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Study closed due to low enrollment rate.
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The purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during ACL reconstruction. We hypothesize that:
Type of Study Double-blinded randomized controlled clinical trial
Group 1 (Control): Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Group 2 (Treatment/Intervention, if applicable): Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case. | |
| Treatment/Intervention | Active Comparator | Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients undergoing ACL reconstruction with or without a tourniquet | Procedure | Patients undergoing ACL reconstruction with or without a tourniquet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Arthroscopic visibility | Arthroscopic visibility | during surgery |
| Operative time | Operative time | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | Sex | preoperative |
| Race | Race | preoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Riboh, MD | OrthoCarolina Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30582107 | Background | Grassi A, Carulli C, Innocenti M, Mosca M, Zaffagnini S, Bait C; SIGASCOT Arthroscopy Committee. New Trends in Anterior Cruciate Ligament Reconstruction: A Systematic Review of National Surveys of the Last 5 Years. Joints. 2018 Sep 27;6(3):177-187. doi: 10.1055/s-0038-1672157. eCollection 2018 Sep. | |
| 10522577 | Background |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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Double-blinded randomized controlled clinical trial
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Treating physicians and subjects will be blinded to treatment group.
| Intra-operative opioid requirements | Intra-operative opioid requirements (in morphine milligram equivalents (MMEs) | during surgery |
| PACU opioid requirements | PACU opioid requirements (MMEs) | during surgery |
| Post-operative pain in PACU | Post-operative pain in PACU measured by a Numeric Rating Scale | during surgery |
| LSI of peak strength and rate of torque development of the quadriceps | LSI of peak strength and rate of torque development of the quadriceps at 6 weeks, 3 months and 6 months as measured using a Tindeq Progressor 3000 dynamometer | 6 weeks |
| LSI of peak strength and rate of torque development of the quadriceps | LSI of peak strength and rate of torque development of the quadriceps at 6 weeks, 3 months and 6 months as measured using a Tindeq Progressor 3000 dynamometer | 6 months |
| Quadriceps circumference | Quadriceps circumference (at the proximal pole of the patella with the knee in extension) at 2 weeks, 6 weeks, 3 months and 6 months post-operatively, as compared to pre-operatively. | preoperative, 2 weeks, 6 weeks, 3 months and 6 months |
| Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy. | Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months |
| Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy. | Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months |
| IKDC and the Marx Activity Rating Scale scores | subjective knee evaluation | 6 weeks |
| IKDC and the Marx Activity Rating Scale scores | subjective knee evaluation | 1 year |
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 6 weeks |
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 3 months |
| Ethnicity |
Ethnicity |
| preoperative |
| Body Mass Index (BMI) | Body Mass Index (BMI) | preoperative |
| Hooper J, Rosaeg OP, Krepski B, Johnson DH. Tourniquet inflation during arthroscopic knee ligament surgery does not increase postoperative pain. Can J Anaesth. 1999 Oct;46(10):925-9. doi: 10.1007/BF03013125. |
| 25786826 | Background | Reda W, ElGuindy AMF, Zahry G, Faggal MS, Karim MA. Anterior cruciate ligament reconstruction; is a tourniquet necessary? A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2948-2952. doi: 10.1007/s00167-015-3582-z. Epub 2015 Mar 19. |
| 28830402 | Background | Kuo LT, Yu PA, Chen CL, Hsu WH, Chi CC. Tourniquet use in arthroscopic anterior cruciate ligament reconstruction: a systematic review and meta-analysis of randomised controlled trials. BMC Musculoskelet Disord. 2017 Aug 22;18(1):358. doi: 10.1186/s12891-017-1722-y. |
| 23809456 | Background | Struijk-Mulder MC, Ettema HB, Verheyen CC, Buller HR. Deep vein thrombosis after arthroscopic anterior cruciate ligament reconstruction: a prospective cohort study of 100 patients. Arthroscopy. 2013 Jul;29(7):1211-6. doi: 10.1016/j.arthro.2013.04.015. |
| 27672574 | Background | Janssen RP, Reijman M, Janssen DM, van Mourik JB. Arterial complications, venous thromboembolism and deep venous thrombosis prophylaxis after anterior cruciate ligament reconstruction: A systematic review. World J Orthop. 2016 Sep 18;7(9):604-17. doi: 10.5312/wjo.v7.i9.604. eCollection 2016 Sep 18. |
| 24371536 | Background | Mingo-Robinet J, Castaneda-Cabrero C, Alvarez V, Leon Alonso-Cortes JM, Monge-Casares E. Tourniquet-related iatrogenic femoral nerve palsy after knee surgery: case report and review of the literature. Case Rep Orthop. 2013;2013:368290. doi: 10.1155/2013/368290. Epub 2013 Nov 26. |
| 20195412 | Background | Lee YG, Park W, Kim SH, Yun SP, Jeong H, Kim HJ, Yang DH. A case of rhabdomyolysis associated with use of a pneumatic tourniquet during arthroscopic knee surgery. Korean J Intern Med. 2010 Mar;25(1):105-9. doi: 10.3904/kjim.2010.25.1.105. Epub 2010 Feb 26. |
| 11447547 | Background | Nicholas SJ, Tyler TF, McHugh MP, Gleim GW. The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: A prospective randomized study. Arthroscopy. 2001 Jul;17(6):603-7. doi: 10.1053/jars.2001.24854. |
| 8947397 | Background | Arciero RA, Scoville CR, Hayda RA, Snyder RJ. The effect of tourniquet use in anterior cruciate ligament reconstruction. A prospective, randomized study. Am J Sports Med. 1996 Nov-Dec;24(6):758-64. doi: 10.1177/036354659602400610. |
| 34960492 | Background | Merry K, Napier C, Chung V, Hannigan BC, MacPherson M, Menon C, Scott A. The Validity and Reliability of Two Commercially Available Load Sensors for Clinical Strength Assessment. Sensors (Basel). 2021 Dec 16;21(24):8399. doi: 10.3390/s21248399. |
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