Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

NARecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

October 27, 2020

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2035

Conditions
Triangular Fibrocartilage Complex Injury
Interventions
PROCEDURE

Arthroscopic Debridement

Wrist arthroscopy can be performed with or without irrigation. In the debridement arm, a central or radial TFCC tear found during arthroscopy is debrided with a shaver. Portals are closed either with sutures or with medical tape. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.

PROCEDURE

Placebo surgery

Diagnostic wrist arthroscopy can be performed with or without irrigation. A central or radial TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed either with sutures or with medical tape. The procedure is performed in general or regional anesthesia in operating room. Participants are not able to see to the operation area or monitor. They will listen to music with noise-cancelling headphones throughout the operation. The operative time will be matched, with the surgeon simulating a debridement procedure. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.

PROCEDURE

Arthroscopic or Open Repair

An ulnar TFCC tear found during wrist arthroscopy is sutured to the capsule or fovea with one of the separately defined methods choosed by the treating hand surgeon. The procedure is performed in general or regional anesthesia in operating room. Wounds are closed and standardized post-operative treatment is started after six weeks.

PROCEDURE

Physiotherapy

An ulnar TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Physiotherapy exercises of wrist and DRUJ stabilizers is started after two weeks.

Trial Locations (9)

2900

RECRUITING

Herlev/Gentofte University Hospital of Copenhagen, Copenhagen

20521

RECRUITING

Turku University Hospital, Turku

33521

RECRUITING

Tampere University Hospital, Tampere

40620

RECRUITING

Hospital Nova of Central Finland, Jyväskylä

70029

RECRUITING

Kuopio University Hospital, Kuopio

90220

RECRUITING

Oulu University Hospital, Oulu

Unknown

RECRUITING

Hospital Sønderjylland, Sønderborg

00029

RECRUITING

Helsinki University Hospital, Helsinki

171 76

RECRUITING

Karolinska University Hospital, Stockholm

All Listed Sponsors
collaborator

Helsinki University Central Hospital

OTHER

collaborator

Turku University Hospital

OTHER_GOV

collaborator

Kuopio University Hospital

OTHER

collaborator

Oulu University Hospital

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

Hospital Sønderjylland

UNKNOWN

collaborator

Copenhagen University Hospital at Herlev

OTHER

collaborator

Hospital Nova of Central Finland

UNKNOWN

lead

Tampere University Hospital

OTHER