Treatment Results After Acute Rupture of the Achilles Tendon.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Akershus
Sponsor:
Collaborators:
Oslo University Hospital
Sykehuset Ostfold
Vestre Viken Hospital Trust
Hjelp24
Information provided by (Responsible Party):
Stale Bergman Myhrvold, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01785264
First received: January 28, 2013
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 (Oslo Skadelegevakt), 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.


Condition Intervention
Rupture of Achilles Tendon
Procedure: Non-operative treatment
Procedure: Open surgery
Procedure: Mini-invasive surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-operative Treatment of Acute Achilles Tendon Ruptures Versus Open and Mini-invasive Surgery: A Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture Score (ATRS) at 12 month follow-up examination. [ Time Frame: The patients are examined at baseline and after 6 and 12 months. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Risk of complications such as infections and reruptures within 12 months after initiation of treatment. [ Time Frame: The patients are examined at baseline and after 6 and 12 months. ] [ Designated as safety issue: No ]
    Secondly, we want to compare the risk of complications such as infections and reruptures. The patients are examined at baseline and after 6 and 12 months. Since there are only minor functional improvements after 12 months, we do not plan any later follow-up as part of the main project. The 6 and 12 months examinations will be completed at the Norwegian Sport Medicine Clinic (NIMI), these examinations are blinded and performed by two physiotherapists who have not been taking part in the study prior to final follow-up. Patients will be wearing knee socks to hide potential scar tissue.


Other Outcome Measures:
  • SF36 after 12 months after initiation of treatment. [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 480
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open surgical repair
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.
Procedure: Non-operative treatment
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.
Procedure: Open surgery
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.
Procedure: Mini-invasive surgery

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.

Active Comparator: Non-operative treatment
Non-operativ treatment starts with casting the ankle in equinus position. The rest of the treatment from there on will be identical to the two minimal invasive and open surgery.
Procedure: Non-operative treatment
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.
Procedure: Open surgery
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.
Procedure: Mini-invasive surgery

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.

Active Comparator: Minimal invasive surgical treatment
Patients allocated to mini-invasive treatment will 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 treatment
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.
Procedure: Open surgery
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.
Procedure: Mini-invasive surgery

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785264

Contacts
Contact: Ståle B Myhrvold, MD +47 90915511 stalemyhrvold@gmail.com
Contact: Sigurd E Hoelsbrekken, MD PhD +47 41042274 s.e.hoelsbrekken@medisin.uio.no

Locations
Norway
Vestre Viken HF Recruiting
Drammen, Vestfold, Norway, 3004
Contact: Faisal Butt, MD    +47 98460254    Faisal.Butt@vestreviken.no   
Principal Investigator: Faisal Butt, MD         
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Ståle B Myhrvold, MD    +47 90915511    stalemyhrvold@gmail.com   
Contact: Sigurd E Hoelsbrekken, PhD    +47 41042274    s.e.hoelsbrekken@medisin.uio.no   
Principal Investigator: Ståle B Myhrvold, MD         
Sub-Investigator: Espen F Brouwer, MD         
Oslo University Hospital Recruiting
Oslo, Norway, 0182
Contact: Agathe Rønning, MD    +47 47753040    agathe.cr@gmail.com   
Contact: Knut Melhuus, MD    +47 22117120    knut.melhuus@uus.no   
Principal Investigator: Agathe Rønning, MD         
Sykehuset Østfold HF Recruiting
Fredrikstad, Østfold, Norway, 1603
Contact: Lars F Høifødt, MD    +47 91149363    Lars.Fredrik.Hoifodt@so-hf.no   
Contact: Asbjørn Sorteberg, MD    +47 95024408    asbsor@so-hf.no   
Principal Investigator: Lars F Høifødt, MD         
Sponsors and Collaborators
University Hospital, Akershus
Oslo University Hospital
Sykehuset Ostfold
Vestre Viken Hospital Trust
Hjelp24
Investigators
Principal Investigator: Ståle B Myhrvold, MD University Hospital, Akershus
Study Chair: Sigurd E Hoelsbrekken, PhD University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Stale Bergman Myhrvold, Consultant orthopedic surgeon, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01785264     History of Changes
Other Study ID Numbers: 2012/530/REK, 2013005
Study First Received: January 28, 2013
Last Updated: February 20, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University Hospital, Akershus:
Achilles
Tendon
Rupture
Acute
Treatment
Outcome measure

Additional relevant MeSH terms:
Rupture
Rupture, Spontaneous
Pathological Conditions, Anatomical
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014