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Arthroscopic Repair Versus Conservative Treatment for Palmer Type 1B Chronic TFCC Injuries: A randomized controlled trial

Arthroscopic Repair Versus Conservative Treatment for Palmer Type 1B Chronic TFCC Injuries: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107093
Enrollment
Unknown
Registered
2025-08-04
Start date
2016-06-06
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triangular Fibrocartilage Complex Injury

Interventions

Arthroscopic Repair Arm group:For peripheral ulnar tears (1B): an arthroscopic TFCC repair will be carried out. The surgeon will reattach the TFCC to its foveal insertion on the ulna, using either an
Conservative Treatment Arm group:The patient will be placed in a cast or orthosis for 6 weeks, similar duration as the surgical arm. We will use a long arm cast (or a custom-molded long forearm splint
additionally, a corticosteroid injection into the TFCC region is allowed before casting if deemed appropriate for pain relief (though not mandatory).

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 50 years (male or female) with a confirmed Palmer type 1B TFCC tear. Confirmation is by clinical examination (ulnar-sided wrist pain, positive TFCC load tests) and imaging (MRI or wrist arthrogram indicating TFCC tear), or diagnostic arthroscopy if already performed; 2. Injury duration of 3 to 6 months from the initial traumatic event or onset of symptoms. (This ensures we include subacute to chronic cases who have persistent symptoms beyond the acute healing period, but exclude very acute injuries 1 year where chronic degeneration might dominate.); 3. Persistent wrist pain, instability, or functional limitation attributable to the TFCC tear despite at least 4 weeks of prior conservative management (e.g. rest, splinting, or therapy); 4. Distal radioulnar joint (DRUJ) stability is intact or only mildly reduced. (Clinical exam shows none or mild laxity; no gross DRUJ dislocation. This is to ensure that non-operative management is a reasonable option. Patients with frank DRUJ instability requiring surgical stabilization are excluded, as they would not be equipoised for conservative care.) 5. Ability to provide informed consent and comply with treatment protocol and follow-up visits (e.g. local resident or able to return for follow-ups).

Exclusion criteria

Exclusion criteria: 1. Palmer type 1C or 1D TFCC tears, or degenerative TFCC lesions (Palmer type 2). The trial focuses only on central and ulnar-sided traumatic tears; 2. Acute TFCC injuries <6 months old, or injuries older than 12 months (to create a relatively uniform chronicity range); 3. Prior wrist surgery involving the TFCC or distal radius/ulna on the affected side (to avoid confounding effects of prior interventions); 4. Concomitant significant wrist pathology that could affect outcomes: e.g. chronic distal radius malunion, advanced osteoarthritis of the wrist or DRUJ, major ligament injuries (scapholunate tear) requiring separate surgical treatment, etc. Minor concomitant injuries (e.g. a small ulnar styloid fracture fragment that is asymptomatic) will be allowed, but anything requiring additional surgery is excluded; 5. Inflammatory arthritis or connective tissue disease affecting the wrist (e.g. rheumatoid arthritis) – these could independently cause ulnar-sided pain or affect healing. 6. Nerve dysfunction (e.g. ulnar neuropathy, complex regional pain syndrome) that would confound pain and function assessment; 7. Pregnancy (if female of childbearing age, a pregnancy test will be done; pregnant patients excluded mainly due to imaging/radiation and anesthesia risks, and altered healing physiology); 8. Contraindications to surgery or anesthesia: such as uncontrolled medical conditions (severe cardiac/pulmonary disease) that make surgery too high-risk. These patients would by necessity receive conservative care, so cannot be randomized; 9. Inability to follow-up or adhere to rehabilitation (e.g. due to severe psychiatric disorders, substance abuse, or lack of social support); 10. Patients insisting on one treatment and unwilling to accept randomization (to preserve equipoise – those who strongly prefer or refuse surgery will not be enrolled).

Design outcomes

Primary

MeasureTime frame
Patient-Rated Wrist Evaluation;

Secondary

MeasureTime frame
Grip strength;Wrist range of motion;Modified Mayo Wrist Score (MMWS);DRUJ stability grade ;Purdue Pegboard Test;EuroQol-5D-5L;

Countries

China

Contacts

Public ContactZhang Wen

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

joint1001@126.com+86 189 3017 2610

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026