Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing

ISRCTN	ISRCTN50141196
DOI	https://doi.org/10.1186/ISRCTN50141196
Secondary identifying numbers	NTR730

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr R Metz
Scientific

Diakonessenhuis
Bosboomstraat 1
Utrecht
3582 KE
Netherlands

Phone	+31 (0)30 2566024
Email	metz_r@hotmail.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing: design of a randomised controlled trial
Study objectives	The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Acute Achilles tendon rupture
Intervention	Patients with acute Achilles tendon rupture will be randomised to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Patient follow-up will be 12 month.
Intervention type	Other
Primary outcome measure	Reduction in complications other than re-rupture.
Secondary outcome measures	1. Re-rupturing 2. Time off work 3. Sporting activity post rupture 4. Functional outcome by Leppilahti score 5. Patient satisfaction
Overall study start date	01/02/2004
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	72
Key inclusion criteria	1. Primary spontaneous Achilles tendon rupture 2. Treatment starts within 72 hours after rupture 3. Diagnoses by physical examination: palpable gap and calf muscle squeeze test positive for tendon rupture 4. Age 18 to 65 years 5. Informed consent
Key exclusion criteria	1. Re-rupture/bilateral rupture/open rupture 2. Combination with fracture of foot or ankle 3. Former application (injection) of local corticosteroids in tendon area 4. Contra-indications for surgery 5. Physical or mental handicaps that do not allow functional treatment or otherwise interfere with the ability to follow-up on the study protocol
Date of first enrolment	01/02/2004
Date of final enrolment	01/10/2006

Diakonessenhuis

Utrecht
3582 KE
Netherlands

University Medical Center Utrecht (UMCU) (The Netherlands)
University/education

Department of Surgery
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

"ROR"	https://ror.org/0575yy874

Research organisation

Research foundation of Heelkunde University Medical Center Utrecht (UMCU) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/11/2007		Yes	No
Results article	results	01/09/2008		Yes	No

13/09/2017: internal review.