Treatment Results After Acute Rupture of the Achilles Tendon.

Sponsor

University Hospital, Akershus (Other)

Overall Status

Completed

CT.gov ID

NCT01785264

Collaborator

Oslo University Hospital (Other), Sykehuset Ostfold (Other), Vestre Viken Hospital Trust (Other), Hjelp24 (Other)

530

Enrollment

Locations

Arms

75.9

Actual Duration (Months)

132.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rupture of Achilles Tendon	Procedure: Non-operative treatment Procedure: Open surgery Procedure: Mini-invasive surgery	N/A

Detailed Description

Patients are randomized to either surgery or non-operative treatment. Surgery will be performed by open technique or by using a mini-invasive approach. Open surgery remains widespread and arguably the best documented treatment, however mini-invasive surgery is also included because of its potential to lessen the risk of wound complications. Michael Amlang and Hans Zwipp at the University of Dresden represent some of the leading foot- and ankle surgeons in Europe. They and their co-workers have developed a protocol for mini-invasive surgery using specially adapted proprietary instruments. Michael Amlang visited Ahus in 2012 teaching the general principles of the Dresden mini-invasive treatment. To ensure optimal and reproducible results, surgeons participating in the study must master both techniques.

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 maintaining ∼12° plantar flexion (three heel lifts). We have chosen to use standardized heel lifts because it eases weightbearing compared to a hinged brace. After two weeks (four weeks from injury) the ankle position is adjusted to ∼8° plantar flexion (two heel lifts) and following additional two weeks the ankle position is adjusted to ∼4° plantar flexion (one heel lift). The last week of the orthosis treatment the heel lift is completely removed. Hence, the brace is retained for a total of six weeks, and patients are allowed full weight bearing as tolerated during the entire time period. The brace is worn day and night for the first two weeks, but is removed during nighttime for the last four weeks. Importantly, the immobilization regimen is identical for all three-treatment groups. To ensure identical rehabilitation following immobilization, physical therapy has to adhere to a standardized protocol supervised by an experienced physiotherapist at the Norwegian Sport Medicine Clinic (NIMI).

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). The system consists of two different jump tests (drop counter-movement jump and hopping), two different strength tests (concentric heel rise and eccentric-concentric heel rise) and one muscular endurance test (standing heel rise) and the system has been shown to be both valid and reliable assessing lower leg function in patients with Achilles tendinopathy. 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. 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.

Although the minimum clinically important difference in ATRS score has yet to be determined, Carmont and coworkers have shown that 7 points represent the smallest detectable change. Moreover, a study by Metz et al. found that patients with reruptures of the achilles tendon presented on average 18 points lower scores whereas patients with injuries of the sural nerve or superficial wound infections presented scores 10 and 9 points lower than average, respectively. In order to detect a difference of 7 points in ATRS score with 80% power there must be 160 patients in each group. Power calculations are based on one-way ANOVA analyses assuming a common standard deviation of 20. This concomitantly allows us to detect differences as low as 8 % with respect to complications. This is of pivotal importance since assessing the risk of reruptures is essential when establishing treatment recommendations. We therefore plan to include a total of 530 patients allowing for expected loss during follow-up. Ahus, The Emergency Department of Oslo University Hospital, Drammen and Fredrikstad Hospitals have a catchment area of nearly 1.3 million people and treats in excess of 300 achilles tendon ruptures annually. This allows for completion of the inclusion period within three years. In our view, this is the first study to include a sufficient number of patients to detect lesser, but yet important differences, and the results will be published in a suitable international peer-reviewed journal.

The prospective randomized trial embodies many different disciplines and will spur off follow-up studies. As part of the main project we will conduct a treatment-cost analysis in relation to individual results. We will also perform an investigation based on ultrasound grading of Achilles tendon ruptures according to a classification system established by Michael Amlang and colleagues. Previous studies have provided evidence suggesting that treatment results may depend on the extension of the injury, and that treatment recommendations should be based on type of rupture sustained. This is of particular interest as it may facilitate individualized treatment. Together with the prospective randomized trial and the treatment-cost analysis, the ultrasound investigation will constitute the core of the Doctor of Philosophy (PhD) project.

Study Design

Study Type:

Interventional

Actual Enrollment :

530 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open surgery 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 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-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 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: Mini-invasive surgery 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 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.

Arm

Intervention/Treatment

Active Comparator: Open surgery

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 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

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-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 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

Procedure: Mini-invasive surgery

Active Comparator: Mini-invasive surgery

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 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

Procedure: Mini-invasive surgery

Outcome Measures

Primary Outcome Measures

The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture Score (ATRS) at 12 month follow-up examination. [The patients are examined at baseline and after 6 and 12 months.]
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. [The patients are examined at baseline and after 6 and 12 months.]
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. [Baseline, 6 and 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Oslo	Lørenskog	Norway	1478
2	Vestre Viken HF	Drammen	Vestfold	Norway	3004
3	Oslo University Hospital	Oslo		Norway	0182
4	Sykehuset Østfold HF	Fredrikstad	Østfold	Norway	1603