NCT01785264

Brief Summary

To compare the end-results of three different methods of treatment of acute achilles tendon ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally, early mobilization has been reserved for patients treated surgically and this may have unintentionally skewed treatment results. The investigators have therefore designed a prospective randomized trial performed as collaboration between Akershus University Hospital (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad) and Drammen Hospital. The four institutions were chosen because of their geographical proximity and because they jointly have a substantial catchment area. Treatment is divided into three arms, and patients between 18 and 60 years of age sustaining first time achilles tendon ruptures will be invited to participate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

6.3 years

First QC Date

January 28, 2013

Last Update Submit

April 30, 2021

Conditions

Rupture of Achilles Tendon

Keywords

AchillesTendonRuptureAcuteTreatmentOutcome measure

Outcome Measures

Primary Outcomes (1)

  • The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture Score (ATRS) at 12 month follow-up examination.

    The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture Score (ATRS). This is a patient-centered self-reporting instrument with good reliability, validity and sensitivity. Furthermore, ATRS will be combined with SF36, another commonly used self-reporting instrument. Pain is evaluated by a visual analogue scale (VAS). Functional results are evaluated by The MuscleLab measurement system (Ergotest Innovation, Porsgrunn, Norway). We will also measure dorsiflexion and plantarflexion range of movement (ROM) as well as the circumference of the calf, all widely used endpoints in similar studies.

    The patients are examined at baseline and after 6 and 12 months.

Secondary Outcomes (1)

  • Risk of complications such as infections and reruptures within 12 months after initiation of treatment.

    The patients are examined at baseline and after 6 and 12 months.

Other Outcomes (1)

  • SF36 after 12 months after initiation of treatment.

    Baseline, 6 and 12 months

Study Arms (3)

Open surgery

ACTIVE COMPARATOR

Treatment is divided into three arms, and patients between 18 and 60 years of age sustaining first time achilles tendon ruptures will be invited to participate. All three groups will have identical rehabilitation protocol. Open surgical repair is done through a 10 cm longitudinal incision, through the fascia curries and the paratenon. After necessary revision of the injure site, the tendons ends is sutured with a double layer, three knot, Krakow whip suture technique. 5 to 10 degrees of overcorrection compared to the uninjured side is endeavored. The paratenon is sewn as much as possible back over the injure site and suture material. The fascia is sutured and then continuous lying mattress skin suture.

Procedure: Non-operative treatmentProcedure: Open surgeryProcedure: Mini-invasive surgery

Non-operative treatment

ACTIVE COMPARATOR

Non-operative treatment starts with casting the ankle in equinus position. The rest of the treatment from there on will be identical to the two other arms: Minimal invasive and open surgery. Casting lasts for 2 weeks for all three arms.

Procedure: Non-operative treatmentProcedure: Open surgeryProcedure: Mini-invasive surgery

Mini-invasive surgery

ACTIVE COMPARATOR

Patients allocated to mini-invasive treatment will (as patients treated with open surgery) be operated within 7 days from injury with the technique developed by Dr Amlang and Prof Zwipp in Dresden. Patients in all three arms will have an active, early weight bearing rehabilitation protocol.

Procedure: Non-operative treatmentProcedure: Open surgeryProcedure: Mini-invasive surgery

Interventions

Non-operative treatmentPROCEDURE

All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none. Patients randomized to non-operative treatment will have a cast applied within 3 days from injury.

Mini-invasive surgeryNon-operative treatmentOpen surgery
Open surgeryPROCEDURE

All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.

Mini-invasive surgeryNon-operative treatmentOpen surgery
Mini-invasive surgeryPROCEDURE

We will use the technique developed by Dr. Amlang and Professor Zwipp from Dresden, Germany. They have developed a protocol of mini-invasive surgery using specially adapted proprietary instruments. All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.

Mini-invasive surgeryNon-operative treatmentOpen surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18 and 60 years of age sustaining first time achilles tendon ruptures will be invited to participate.
  • The injury must be addressed with a below the knee cast in equinus position within 3 days from injury.
  • The operations must be carried out within 7 days from injury.

You may not qualify if:

  • Age below 18 or above 60 years
  • The use of quinolone antibiotics within 6 months prior to injury
  • Former achilles tendon injury on either side
  • Steroid injections close to the achilles tendon the last 6 months
  • The use of systemic steroids (prednisolon)
  • Diabetes mellitus
  • Dependent on walking aids
  • Not able to undergo the rehabilitation protocol
  • Not willing to perform the controls on the hospitals and examinations at NIMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Akershus University Hospital

Oslo, Lørenskog, 1478, Norway

Location

Vestre Viken HF

Drammen, Vestfold, 3004, Norway

Location

Oslo University Hospital

Oslo, 0182, Norway

Location

Sykehuset Østfold HF

Fredrikstad, Østfold fylke, 1603, Norway

Location

Related Publications (1)

  • Myhrvold SB, Brouwer EF, Andresen TKM, Rydevik K, Amundsen M, Grun W, Butt F, Valberg M, Ulstein S, Hoelsbrekken SE. Nonoperative or Surgical Treatment of Acute Achilles' Tendon Rupture. N Engl J Med. 2022 Apr 14;386(15):1409-1420. doi: 10.1056/NEJMoa2108447.

    PMID: 35417636DERIVED

MeSH Terms

Conditions

Rupture

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ståle B Myhrvold, MD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

  • Sigurd E Hoelsbrekken, PhD

    University Hospital, Akershus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant orthopedic surgeon

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(4)