Early Viscosupplementation After ACL Reconstruction: a Randomized Controlled Trial

NCT02630407 | Completed Phase 4 DMC

• 1 other identifier: Rizzoli HA-ACL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems attractive. The aim of the present double blind, placebo controlled study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction. The day after the ACL reconstruction (which is performed with the same technique for all the patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted it to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure. All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• Change in IKDC (International Knee Documentation Committee) Subjective score

  basal, 6 and 12 months post-op

Secondary Outcomes (10)

• Change in Tegner Score

  basal, 6 and 12 months

• Transpatellar circumference trend

  basal, 15, 30, 60, 180 days post op

• Trend in Active and Passive Range of Motion (ROM) of the knee

  basal, 15, 30, 60, 180 days post op

• Change in VAS (Visual Analogue Scale) for general health status

  basal, 15, 30, 60, 180 days post op

• Change in VAS for pain

  basal, 15, 30, 60, 180 days post op

Study Arms (2)

Hyaluronic acid group

EXPERIMENTAL

Single injection of 3 ml HA (product name: Hymovis, Fidia Spa, Padova, Italy) the day after ACL reconstruction (after drainage removal)

Biological: viscosupplementation

Placebo group

PLACEBO COMPARATOR

Single injection of 3 ml saline solution the day after ACL reconstruction (after drainage removal)

Other: Placebo group

Interventions

viscosupplementation BIOLOGICAL

A single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal

Hyaluronic acid group

Placebo group OTHER

A single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic and symptomatic ACL tear requiring primary surgical reconstruction;
• age between 18 and 50 years;

You may not qualify if:

• concurrent articular lesion requiring surgical treatment (just isolated partial meniscectomy was permitted)
• axial mal-alignment in the index limb
• unhealthy contra-lateral knee (i.e. functional limitation or pain)
• concurrent rheumatic or metabolic disease
• alterations in the other joints of the index limb (e.g.: hip or ankle disease)
• previous ACL reconstruction in the index knee

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

II Orthopaedic Clinic, Rizzoli Orthopaedic Institute

Bologna, Emilia-Romagna, 40136, Italy

Location

Related Publications (9)

• Monticone M, Frizziero A, Rovere G, Vittadini F, Uliano D, LA Bruna S, Gatto R, Nava C, Leggero V, Masiero S. Hyaluronic acid intra-articular injection and exercise therapy: effects on pain and disability in subjects affected by lower limb joints osteoarthritis. A systematic review by the Italian Society of Physical and Rehabilitation Medicine (SIMFER). Eur J Phys Rehabil Med. 2016 Jun;52(3):389-99. Epub 2015 Sep 10.

  PMID: 26365146 BACKGROUND

• Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, Chevalier X, Migliore A. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015 Oct;45(2):140-9. doi: 10.1016/j.semarthrit.2015.04.011. Epub 2015 Apr 30.

  PMID: 26094903 BACKGROUND

• Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, Bach BR Jr, Cole BJ, Verma NN. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Oct;31(10):2036-45.e14. doi: 10.1016/j.arthro.2015.03.030. Epub 2015 May 19.

  PMID: 25998016 BACKGROUND

• Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.

  PMID: 25952818 BACKGROUND

• Macdonald SA, Heard SM, Hiemstra LA, Buchko GM, Kerslake S, Sasyniuk TM. A comparison of pain scores and medication use in patients undergoing single-bundle or double-bundle anterior cruciate ligament reconstruction. Can J Surg. 2014 Jun;57(3):E98-104. doi: 10.1503/cjs.018612.

  PMID: 24869623 BACKGROUND

• Braithwaite GJ, Daley MJ, Toledo-Velasquez D. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence. J Biomater Sci Polym Ed. 2016;27(3):235-46. doi: 10.1080/09205063.2015.1119035. Epub 2015 Dec 31.

  PMID: 26569146 BACKGROUND

• Chau JY, Chan WL, Woo SB, Cheng SC, Wong TM, Wong TK, Yen CH, Wong K, Wong WC. Hyaluronic acid instillation following arthroscopic anterior cruciate ligament reconstruction: a double-blinded, randomised controlled study. J Orthop Surg (Hong Kong). 2012 Aug;20(2):162-5. doi: 10.1177/230949901202000205.

  PMID: 22933671 BACKGROUND

• Huang MH, Yang RC, Chou PH. Preliminary effects of hyaluronic acid on early rehabilitation of patients with isolated anterior cruciate ligament reconstruction. Clin J Sport Med. 2007 Jul;17(4):242-50. doi: 10.1097/JSM.0b013e31812570fa.

  PMID: 17620776 BACKGROUND

• Di Martino A, Tentoni F, Di Matteo B, Cavicchioli A, Lo Presti M, Filardo G, Zaffagnini S, Marcacci M, Kon E. Early Viscosupplementation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2016 Oct;44(10):2572-2578. doi: 10.1177/0363546516654909. Epub 2016 Jul 27.

  PMID: 27466224 DERIVED

MeSH Terms

Interventions

Viscosupplementation

Intervention Hierarchy (Ancestors)

Injections, Intra-Articular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Orthopedic Procedures

Study Officials

• Elizaveta Kon, MD

  II Clinic & Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BScD

Model Details: injection of saline VS injection of Hyaluronic acid

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 15, 2015
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

IT (1)