Comparison of Functional Bracing vs Rigid Immobilization After Modified Percutaneous Achilles Tendon Repair

NCT04692883 | Completed

• 1 other identifier: KME 54/03/00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale There is ongoing controversy over the optimal treatment and rehabilitation strategy of an acute Achilles tendon rupture (ATR). The highest general complication rate is reported in patients treated with percutaneous repair and early mobilization. Objectives The purpose of the study is to compare the results of two ways of postoperative regimen after treatment with the modified and biomechanically significantly stronger percutaneous repair under local anesthesia. Methods \& Population All the consecutive patients with an acute complete Achilles tendon rupture who will agree to take part in a study will be randomized after a modified percutaneous repair under local anesthesia into functional group (FG), using a modified brace and immobilization group (IG), wearing a rigid plaster, in both groups for the period of 6 weeks. After that they will follow the same (standardized) rehabilitation protocol. Major and minor complication rate, diameter of the healed tendon, active and passive ankle range of motion (using neutral zero method), standing heel-rise test (with 25 repetition within a minute for a grade of normal) and clinical outcome using American Foot and Ankle Society (AOFAS) hindfoot-ankle score, return to the previous activity level, presence of associated complaints and subjective assessment (scored as good, fair or poor) will be assessed. Time frame This will be a 4-year study with a 3-year follow-up. Expected outcomes: There will be no differences in demographic parameters (age, gender, side and mechanism of the injury) between groups. Patients in the FG will reach sooner final range of motion (ROM) and muscular strength without limping and will be (subjectively) more satisfied with the treatment. There will be no statistically significant differences observed between groups according to the number of complications and in the end functional results with return to pre-injury activities.

Conditions

Achilles Tendon Rupture; Percutaneous Repair; Local Anesthesia; Postoperative Complications

Keywords

Achilles tendon; Percutaneous repair; Local anesthesia; Functional treatment; Early mobilization; Rigid immobilization

Outcome Measures

Primary Outcomes (4)

• Change in Post-operative range of motion

  Assessment in change of dorsiflexion (maximum 0-20 degrees) and plantar flexion (maximum 0-50 degrees), measured with goniometer (Reference: Ryf C, Weyman A. The Neutral Zero Method - A Principle of Measuring Joint Function. Injury. 1995;26(Suppl 1)).

  After 2 months, 3 months, 6 months, 12 months and after 3 years post op.

• Change in Post-operative strength

  Heel rise test (rising on toes with both legs, operated leg and non-operated leg, 25 times in 60 seconds). (Reference: Lunsford BR, Perry J. The standing heel-rise test for ankle plantar flexion: criterion for normal. Phys Ther. 1995;75:694-8).

  After 3 months, 6 months, 12 months and after 3 years post op.

• Number of complications

  Clinical findings of occurence * Major complications (Rerupture, Second rerupture, Permanent equinus position of the foot, Extreme lengthening of the Achilles tendon, Deep infection, Chronic fistula, Necrosis of the skin, Deep vein Thrombosis, Embolism, Death) and * Minor complications (Superficial infection, Wound hematoma, Delayed wound healing, Adhesion of the scar, Disturbances of sensibility, Suture granuloma, Suture rupture)

  Final results after 3 years

• American Foot and Ankle Society (AOFAS) hindfoot-ankle score

  Filling of AOFAS questionnaire (0 - worst outcome, 100 - best outcome) (reference: 1.Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994;15:349-53.)

  Final result after 3 years

Secondary Outcomes (3)

• Patient's subjective assessment of treatment

  Final assessment after 3 years

• Patient's report to previous activities

  Final assessment after 3 years

• Patient's report about return to sports activities

  Final assessment after 3 years

Interventions

Percutaneous suturing PROCEDURE

Also known as: Functional bracing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 18 years of age or older
• a rupture that occurred no more than 7 days before the operating procedure
• closed, complete ATR
• a rupture that occurred in the tendinous portion (2-8 cm proximal to the insertion)
• informed consent

You may not qualify if:

• no previous operative procedures or history of partial or complete rupture of the involved tendon
• no previous local, oral or parenteral therapy that might have weakened the tendon (for instance local infiltration of anesthetics or steroids in the AT region, oral or parenteral immunosuppressive therapy in patients with transplanted organs or immune diseases etc.).

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

University Medical Centre Maribor, Ljubljanska 5

Maribor, 2000, Slovenia

Location

Related Publications (3)

• Cretnik A, Zlajpah L, Smrkolj V, Kosanovic M. The strength of percutaneous methods of repair of the Achilles tendon: a biomechanical study. Med Sci Sports Exerc. 2000 Jan;32(1):16-20. doi: 10.1097/00005768-200001000-00004.

  PMID: 10647524 BACKGROUND

• Wong J, Barrass V, Maffulli N. Quantitative review of operative and nonoperative management of achilles tendon ruptures. Am J Sports Med. 2002 Jul-Aug;30(4):565-75. doi: 10.1177/03635465020300041701.

  PMID: 12130412 BACKGROUND

• Cretnik A, Kosanovic M, Smrkolj V. Percutaneous suturing of the ruptured Achilles tendon under local anesthesia. J Foot Ankle Surg. 2004 Mar-Apr;43(2):72-81. doi: 10.1053/j.jfas.2004.01.008.

  PMID: 15057852 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrej Cretnik, MD, PhD

  University Medical Center Maribor, Ljubljanska 5, 2000 Maribor, Slovenia

  PRINCIPAL INVESTIGATOR

• Roman Košir, MD, PhD

  University Medical Center Maribor, Ljubljanska 5, 2000 Maribor, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, principal investigator (Ass. Prof.)

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2001
• Primary Completion: December 31, 2004
• Study Completion: December 31, 2007
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)